Fresh Recalls

Drug recalls

432 recent drug recalls in our current data. Showing 1–200, newest first.

FDA Not Yet Classified · Drug · October 14, 2026

Tri-Immune Boost (Glutathione recall — Centric Compounding LLC

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Company / brand: Centric Compounding recalls

Affected product: Tri-Immune Boost (Glutathione recall status

Official ID EVT-99860-15i85aw · Official record ↗

FDA Class II · Drug · October 14, 2026

Apothecary NAD+ Injection 200 mg/mL recall — Apothecary Pharma LLC

Lack of Assurance of Sterility

Company / brand: Apothecary Pharma recalls

Affected product: Apothecary NAD+ Injection 200 mg/mL recall status

Official ID D-0037-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tirzepatide Injection recall — Apothecary Pharma LLC

Lack of Assurance of Sterility

Company / brand: Apothecary Pharma recalls

Affected product: Tirzepatide Injection recall status

Official ID D-0036-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream UPS recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Tretinoin Cream UPS recall status

Official ID D-0035-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream USP recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Tretinoin Cream USP recall status

Official ID D-0034-2027 · Official record ↗

FDA Class III · Drug · October 14, 2026

Tretinoin Cream USP recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Tretinoin Cream USP recall status

Official ID D-0033-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0032-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0031-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE recall status

Official ID D-0030-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE recall status

Official ID D-0029-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE recall status

Official ID D-0028-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE recall status

Official ID D-0027-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE recall status

Official ID D-0026-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0025-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0024-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0023-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Tri-MIX (PAPAV/PHENTO/ALPROS) recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: Tri-MIX (PAPAV/PHENTO/ALPROS) recall status

Official ID D-0022-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE recall status

Official ID D-0021-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SERMORELIN ACETATE 1 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: SERMORELIN ACETATE 1 MG/ML INJECTABLE recall status

Official ID D-0020-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE recall status

Official ID D-0019-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

SEMAGLUTIDE 3 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: SEMAGLUTIDE 3 MG/ML INJECTABLE recall status

Official ID D-0018-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

TIRZEPATIDE 26 MG/ML INJECTABLE recall — Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Company / brand: Carolina Infusion recalls

Affected product: TIRZEPATIDE 26 MG/ML INJECTABLE recall status

Official ID D-0017-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

IMAAVY (nipocalimab-aahu) Injection recall — J&J INNOVATIVE MEDICINE

Presence of particulate matter.

Company / brand: J&J INNOVATIVE MEDICINE recalls

Affected product: IMAAVY (nipocalimab-aahu) Injection recall status

Official ID D-0016-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Fosfomycin Tromethamine Granules for Oral Solution recall — Cipla USA, Inc.

Failed Impurities/Degradation Specifications

Company / brand: Cipla USA recalls

Affected product: Fosfomycin Tromethamine Granules for Oral Solution recall status

Official ID D-0014-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Lidocaine Ointment USP recall — Preferred Pharmaceuticals, Inc.

Failed Content Uniformity Specifications

Company / brand: Preferred Pharmaceuticals recalls

Affected product: Lidocaine Ointment USP recall status

Official ID D-0013-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Biospectra Tris/Tromethamine recall — BioSpectra, Inc.

Failed stability specifications

Company / brand: BioSpectra recalls

Affected product: Biospectra Tris/Tromethamine recall status

Official ID D-0012-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400 recall status

Official ID D-0009-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Eye Drops Redness Relief (Glycerin 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile Eye Drops Redness Relief (Glycerin 0 recall status

Official ID D-0008-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Eye Drops recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile Eye Drops recall status

Official ID D-0007-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile Lubricant Dry Eye Relief Eye Drops recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile Lubricant Dry Eye Relief Eye Drops recall status

Official ID D-0006-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Eye Drops MAXIMUM recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Eye Drops MAXIMUM recall status

Official ID D-0005-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile EYE DROPS Advanced Relief recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile EYE DROPS Advanced Relief recall status

Official ID D-0004-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Sterile EYE DROPS AC (tetrahydrozoline HCl 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Sterile EYE DROPS AC (tetrahydrozoline HCl 0 recall status

Official ID D-0003-2027 · Official record ↗

FDA Class II · Drug · October 14, 2026

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0 recall — K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

Company / brand: K.C. Pharmaceuticals recalls

Affected product: Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0 recall status

Official ID D-0002-2027 · Official record ↗

FDA Not Yet Classified · Drug · October 7, 2026

amazon recall — Aurobindo Pharma USA Inc

Discoloration: consumer complaints received for discolored tablets

Company / brand: Aurobindo Pharma USA recalls

Affected product: amazon recall status

Official ID EVT-99934-1f1l4x9 · Official record ↗

FDA Class II · Drug · October 7, 2026

Benzoyl Peroxide Wash recall — SV Labs Toronto Corporation

Microbial contamination of topical product.

Company / brand: SV Labs Toronto recalls

Affected product: Benzoyl Peroxide Wash recall status

Official ID D-0879-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Benzoyl Peroxide Wash recall — SV Labs Toronto Corporation

Microbial contamination of topical product.

Company / brand: SV Labs Toronto recalls

Affected product: Benzoyl Peroxide Wash recall status

Official ID D-0878-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Paroxetine Extended-Release Tablets recall — Apotex Corp.

Failed dissolution specifications.

Company / brand: Apotex recalls

Affected product: Paroxetine Extended-Release Tablets recall status

Official ID D-0877-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Buprenorphine Hydrochloride recall — Par Health USA, LLC

Crystallization

Company / brand: Par Health USA recalls

Affected product: Buprenorphine Hydrochloride recall status

Official ID D-0876-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Zoladex (goserelin) implant recall — TerSera Therapeutics LLC

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Company / brand: TerSera Therapeutics recalls

Affected product: Zoladex (goserelin) implant recall status

Official ID D-0875-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

FOCUS PI Hypromellose 0 recall — Aurolab Trust

Lack of Assurance of Sterility

Company / brand: Aurolab Trust recalls

Affected product: FOCUS PI Hypromellose 0 recall status

Official ID D-0874-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Estradiol Gel recall — Amneal Pharmaceuticals, LLC

Defective Container; packets were found to be either empty or partially full.

Company / brand: Amneal Pharmaceuticals recalls

Affected product: Estradiol Gel recall status

Official ID D-0873-2026 · Official record ↗

FDA Class II · Drug · October 7, 2026

Ranolazine Extended-Release Tablets recall — Ajanta Pharma USA Inc

Failed Dissolution Specifications: below specification

Company / brand: Ajanta Pharma USA recalls

Affected product: Ranolazine Extended-Release Tablets recall status

Official ID D-0010-2027 · Official record ↗

FDA Not Yet Classified · Drug · September 30, 2026

0 recall — Otsuka ICU Medical LLC

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual produc…

Company / brand: Otsuka ICU Medical recalls

Affected product: 0 recall status

Official ID EVT-99892-f8gl50 · Official record ↗

FDA Class II · Drug · September 30, 2026

Clear Eyes Redness Relief recall — Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Lack of Assurance of Sterility

Company / brand: Insight Pharmaceuticals recalls

Affected product: Clear Eyes Redness Relief recall status

Official ID D-0871-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Clear Eyes Redness Relief recall — Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Lack of Assurance of Sterility

Company / brand: Insight Pharmaceuticals recalls

Affected product: Clear Eyes Redness Relief recall status

Official ID D-0870-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Exenatide Injection recall — Amneal Pharmaceuticals of New York, LLC

Defective Delivery System: Possibility of no medication in the prefilled pen.

Company / brand: Amneal Pharmaceuticals of New York recalls

Affected product: Exenatide Injection recall status

Official ID D-0868-2026 · Official record ↗

FDA Class III · Drug · September 30, 2026

Olanzapine Tablets recall — Macleods Pharmaceuticals Limited

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Company / brand: Macleods Pharmaceuticals recalls

Affected product: Olanzapine Tablets recall status

Official ID D-0867-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0 recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0 recall status

Official ID D-0863-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Lubricant Eye Drops-Cameron Pharmaceuticals recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Lubricant Eye Drops-Cameron Pharmaceuticals recall status

Official ID D-0862-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Major LubriFresh P recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Major LubriFresh P recall status

Official ID D-0861-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recall status

Official ID D-0860-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Reliable-1 Laboratories Lubricating Tears recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Reliable-1 Laboratories Lubricating Tears recall status

Official ID D-0859-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Walgreens Lubricant Eye Drops recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Walgreens Lubricant Eye Drops recall status

Official ID D-0858-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Walgreens Lubricant Eye Drops recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Walgreens Lubricant Eye Drops recall status

Official ID D-0857-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

Reliable -1 Laboratories recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: Reliable -1 Laboratories recall status

Official ID D-0856-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0 recall — Sterling Pharmaceutical Services LLC

Lack of Assurance of Sterility

Company / brand: Sterling Pharmaceutical Services recalls

Affected product: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0 recall status

Official ID D-0855-2026 · Official record ↗

FDA Class II · Drug · September 30, 2026

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ recall — SHANTOU Qiwei industrial Co., Ltd

cGMP Deviations

Company / brand: SHANTOU Qiwei industrial Co recalls

Affected product: MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ recall status

Official ID D-0854-2026 · Official record ↗

FDA Not Yet Classified · Drug · September 23, 2026

Nystatin Cream recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Stability Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Nystatin Cream recall status

Official ID EVT-99876-z42zg7 · Official record ↗

FDA Class I · Drug · September 23, 2026

Thyroid Tablets recall — VITRUVIAS THERAPEUTICS INC

Superpotent Drug

Company / brand: VITRUVIAS THERAPEUTICS recalls

Affected product: Thyroid Tablets recall status

Official ID D-0866-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Dopamine HCl Inj recall — Pfizer

Lack of Assurance of Sterility

Company / brand: Pfizer recalls

Affected product: Dopamine HCl Inj recall status

Official ID D-0853-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Chlorthalidone Tablets recall — Inventia Healthcare Limited

Failed Dissolution Specifications

Company / brand: Inventia Healthcare recalls

Affected product: Chlorthalidone Tablets recall status

Official ID D-0852-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Lidocaine Ointment USP recall — SUN PHARMA /TARO

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Company / brand: SUN PHARMA /TARO recalls

Affected product: Lidocaine Ointment USP recall status

Official ID D-0848-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0846-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0845-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0844-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0843-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0842-2026 · Official record ↗

FDA Class II · Drug · September 23, 2026

Fluphenazine HCl Elixir recall — Safecor Health, LLC

Failed Stability Specifications

Company / brand: Safecor Health recalls

Affected product: Fluphenazine HCl Elixir recall status

Official ID D-0841-2026 · Official record ↗

FDA Not Yet Classified · Drug · September 16, 2026

fentaNYL Citrate recall — OurPharma LLC

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Company / brand: OurPharma recalls

Affected product: fentaNYL Citrate recall status

Official ID EVT-99837-1lubpwm · Official record ↗

FDA Class I · Drug · September 16, 2026

0 recall — B BRAUN MEDICAL INC

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Company / brand: B BRAUN MEDICAL recalls

Affected product: 0 recall status

Official ID D-0869-2026 · Official record ↗

FDA Class I · Drug · September 16, 2026

Epinephrine Injection recall — American Regent, Inc.

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Company / brand: American Regent recalls

Affected product: Epinephrine Injection recall status

Official ID D-0865-2026 · Official record ↗

FDA Class II · Drug · September 16, 2026

fentaNYL Citrate recall — OurPharma LLC

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Company / brand: OurPharma recalls

Affected product: fentaNYL Citrate recall status

Official ID D-0864-2026 · Official record ↗

FDA Class I · Drug · September 16, 2026

Dextrose Injection recall — Baxter Healthcare Corporation

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Company / brand: Baxter Healthcare recalls

Affected product: Dextrose Injection recall status

Official ID D-0850-2026 · Official record ↗

FDA Class III · Drug · September 16, 2026

Fluphenazine Hydrochloride Tablets recall — Ajanta Pharma USA Inc

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 …

Company / brand: Ajanta Pharma USA recalls

Affected product: Fluphenazine Hydrochloride Tablets recall status

Official ID D-0836-2026 · Official record ↗

FDA Class III · Drug · September 16, 2026

Povidone Iodine 1 recall — ImprimisRx NJ LLC

Subpotent Drug

Company / brand: ImprimisRx NJ recalls

Affected product: Povidone Iodine 1 recall status

Official ID D-0835-2026 · Official record ↗

FDA Not Yet Classified · Drug · September 9, 2026

Prasugrel HCI recall — Golden State Medical Supply Inc.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Company / brand: Golden State Medical Supply recalls

Affected product: Prasugrel HCI recall status

Official ID EVT-99732-3aiyt7 · Official record ↗

FDA Class I · Drug · September 9, 2026

Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACY

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Company / brand: OPTIMAL BALANCE PHARMACY recalls

Affected product: Glutathione 200 mg/mL recall status

Official ID D-0851-2026 · Official record ↗

FDA Class I · Drug · September 9, 2026

0 recall — Baxter Healthcare Corporation

Presence of particulate matter: Particulates identified as fiberglass

Company / brand: Baxter Healthcare recalls

Affected product: 0 recall status

Official ID D-0849-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Prasugrel HCI recall — Golden State Medical Supply Inc.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Company / brand: Golden State Medical Supply recalls

Affected product: Prasugrel HCI recall status

Official ID D-0847-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Buprenorphine Sublingual Tablets (C-III) recall — American Health Packaging

Labeling: Label Mix-up

Company / brand: American Health Packaging recalls

Affected product: Buprenorphine Sublingual Tablets (C-III) recall status

Official ID D-0840-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Prasugrel Tablets recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Company / brand: Mylan Pharmaceuticals recalls

Affected product: Prasugrel Tablets recall status

Official ID D-0839-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Revcovi (elapegademase-lvlr) Injection recall — Chiesi USA, Inc.

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Company / brand: Chiesi USA recalls

Affected product: Revcovi (elapegademase-lvlr) Injection recall status

Official ID D-0838-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

2% Chlorhexidine Gluconate* Cloth recall — Sage Products, LLC

Cross Contamination with Other Products

Company / brand: Sage Products recalls

Affected product: 2% Chlorhexidine Gluconate* Cloth recall status

Official ID D-0837-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

traZODone Hydrochloride Tablets recall — Teva Pharmaceuticals USA, Inc

Presence of Foreign Tablets/Capsules

Company / brand: Teva Pharmaceuticals USA recalls

Affected product: traZODone Hydrochloride Tablets recall status

Official ID D-0834-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Trokendi XR recall — Supernus Pharmaceuticals, Inc.

Failed dissolution specifications.

Company / brand: Supernus Pharmaceuticals recalls

Affected product: Trokendi XR recall status

Official ID D-0833-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Carton label recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

Company / brand: Mylan Pharmaceuticals recalls

Affected product: Carton label recall status

Official ID D-0830-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Broadway Joe's Pain Cream recall — Lexia LLC

CGMP Deviations: Potential contamination of raw material

Company / brand: Lexia recalls

Affected product: Broadway Joe's Pain Cream recall status

Official ID D-0829-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Broadway Joe's Pain Cream recall — Lexia LLC

CGMP Deviations: Potential contamination of raw material

Company / brand: Lexia recalls

Affected product: Broadway Joe's Pain Cream recall status

Official ID D-0828-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Affected product: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall status

Official ID D-0826-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Affected product: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall status

Official ID D-0825-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Affected product: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall status

Official ID D-0824-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall — Allies Group Inc.

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

Company / brand: Allies Group recalls

Affected product: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall status

Official ID D-0823-2026 · Official record ↗

FDA Class III · Drug · September 9, 2026

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recall — Bionpharma Inc.

Presence of Foreign Tablets/Capsules

Company / brand: Bionpharma recalls

Affected product: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg recall status

Official ID D-0822-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Daptomycin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Daptomycin recall status

Official ID D-0821-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vancomycin Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Vancomycin Injection recall status

Official ID D-0820-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vasopressin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Vasopressin recall status

Official ID D-0819-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Clindamycin Injection USP in 5% Dextrose recall status

Official ID D-0818-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Clindamycin Injection USP in 5% Dextrose recall status

Official ID D-0817-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Phosphate in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Clindamycin Phosphate in 0 recall status

Official ID D-0816-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Clindamycin Injection USP in 5% Dextrose recall status

Official ID D-0815-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Nexterone (amiodarone HCI) recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Nexterone (amiodarone HCI) recall status

Official ID D-0814-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

CARDENE IV (Nicardipine Hydrochloride) in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: CARDENE IV (Nicardipine Hydrochloride) in 0 recall status

Official ID D-0813-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Pantoprazole Sodium in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Pantoprazole Sodium in 0 recall status

Official ID D-0812-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vasopressin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Vasopressin recall status

Official ID D-0811-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Dexmedetomidine Hydrochloride in 0 recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Dexmedetomidine Hydrochloride in 0 recall status

Official ID D-0810-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Famotidine Injection in Sodium Chloride Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Famotidine Injection in Sodium Chloride Injection recall status

Official ID D-0809-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Clindamycin Injection USP in 5% Dextrose recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Clindamycin Injection USP in 5% Dextrose recall status

Official ID D-0808-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Daptomycin recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Daptomycin recall status

Official ID D-0807-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

MYXREDLIN recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: MYXREDLIN recall status

Official ID D-0806-2026 · Official record ↗

FDA Class II · Drug · September 9, 2026

Vancomycin Injection recall — Baxter Healthcare Corporation

CGMP Deviations

Company / brand: Baxter Healthcare recalls

Affected product: Vancomycin Injection recall status

Official ID D-0805-2026 · Official record ↗

FDA Not Yet Classified · Drug · September 2, 2026

Ibuprofen recall — Safecor Health, LLC

Cross Contamination with Other Products

Company / brand: Safecor Health recalls

Affected product: Ibuprofen recall status

Official ID EVT-99666-wagogx · Official record ↗

FDA Class I · Drug · September 2, 2026

Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INC

Presence of Particulate matter.

Company / brand: B BRAUN MEDICAL recalls

Affected product: Lactated Ringer's Injection USP recall status

Official ID D-0832-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Ramipril Capsules USP recall — Hikma Pharmaceuticals USA INC.

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Company / brand: Hikma Pharmaceuticals USA recalls

Affected product: Ramipril Capsules USP recall status

Official ID D-0831-2026 · Official record ↗

FDA Class I · Drug · September 2, 2026

Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLC

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Company / brand: Fresenius Kabi USA recalls

Affected product: Tyenne (tocilizumab-aazg) Injection recall status

Official ID D-0827-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Paxil CR recall — Apotex Corp.

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Company / brand: Apotex recalls

Affected product: Paxil CR recall status

Official ID D-0804-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Acthar Gel (repository corticotropin injection) recall — Mallinckrodt Hospital Products Inc.

Presence of particulate matter: glass and stopper piece

Company / brand: Mallinckrodt Hospital Products recalls

Affected product: Acthar Gel (repository corticotropin injection) recall status

Official ID D-0803-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Zicam recall — Church & Dwight Co., Inc.

CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

Company / brand: Church & Dwight Co recalls

Affected product: Zicam recall status

Official ID D-0790-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Clobetasol Propionate Cream USP recall — Lupin Pharmaceuticals Inc.

Failed content uniformity specifications.

Company / brand: Lupin Pharmaceuticals recalls

Affected product: Clobetasol Propionate Cream USP recall status

Official ID D-0789-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0786-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0785-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0784-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0783-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0782-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0781-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0780-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0779-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0778-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0777-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0776-2026 · Official record ↗

FDA Class II · Drug · September 2, 2026

Levothyroxine Sodium Tablets recall — ACCORD HEALTHCARE, INC.

Subpotent Drug

Company / brand: ACCORD HEALTHCARE recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0775-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

niCARdipine Hydrochloride Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: niCARdipine Hydrochloride Injection recall status

Official ID D-0802-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Tralement (trace elements injection 4* recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Tralement (trace elements injection 4* recall status

Official ID D-0801-2026 · Official record ↗

FDA Class I · Drug · August 26, 2026

Papaverine HCl Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Papaverine HCl Injection recall status

Official ID D-0800-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Multrys (Trace Elements Injection 4 recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Multrys (Trace Elements Injection 4 recall status

Official ID D-0799-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Selenious Acid Injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Selenious Acid Injection recall status

Official ID D-0798-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

ACETYLCYSTEINE SOLUTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: ACETYLCYSTEINE SOLUTION recall status

Official ID D-0797-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

ACETYLCYSTEINE SOLUTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: ACETYLCYSTEINE SOLUTION recall status

Official ID D-0796-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Atropine Sulfate injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Atropine Sulfate injection recall status

Official ID D-0795-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

AMINAOCAPROIC ACID INJECTION recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: AMINAOCAPROIC ACID INJECTION recall status

Official ID D-0794-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Cyanocobalamin injection USP recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Cyanocobalamin injection USP recall status

Official ID D-0793-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Cyanocobalamin injection USP recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Cyanocobalamin injection USP recall status

Official ID D-0792-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Nitroglycerin injection recall — American Regent, Inc.

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Company / brand: American Regent recalls

Affected product: Nitroglycerin injection recall status

Official ID D-0791-2026 · Official record ↗

FDA Class I · Drug · August 26, 2026

Morphine Sulfate Injection recall — Fresenius Kabi USA, LLC

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Company / brand: Fresenius Kabi USA recalls

Affected product: Morphine Sulfate Injection recall status

Official ID D-0788-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Acamprosate Calcium recall — Mylan Pharmaceuticals Inc

Failed Dissolution Specifications

Company / brand: Mylan Pharmaceuticals recalls

Affected product: Acamprosate Calcium recall status

Official ID D-0774-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Carbamazepine Tablets recall — Golden State Medical Supply Inc.

CGMP deviations: tablets with black specks.

Company / brand: Golden State Medical Supply recalls

Affected product: Carbamazepine Tablets recall status

Official ID D-0771-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Carbamazepine Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Carbamazepine Tablets recall status

Official ID D-0770-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

Libtayo (cemiplimab-rwlc) Injection recall — Regeneron Pharmaceuticals Inc

Lack of Assurance of Sterility

Company / brand: Regeneron Pharmaceuticals recalls

Affected product: Libtayo (cemiplimab-rwlc) Injection recall status

Official ID D-0767-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

PEMRYDI RTU(pemetrexed injection) recall — Shilpa Medicare Limited

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Company / brand: Shilpa Medicare recalls

Affected product: PEMRYDI RTU(pemetrexed injection) recall status

Official ID D-0765-2026 · Official record ↗

FDA Class II · Drug · August 26, 2026

PEMRYDI RTU (pemetrexed injection) recall — Shilpa Medicare Limited

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Company / brand: Shilpa Medicare recalls

Affected product: PEMRYDI RTU (pemetrexed injection) recall status

Official ID D-0764-2026 · Official record ↗

FDA Not Yet Classified · Drug · August 19, 2026

Cefazolin in Dextrose recall — Baxter Healthcare Corporation

Presence of Particulate Matter

Company / brand: Baxter Healthcare recalls

Affected product: Cefazolin in Dextrose recall status

Official ID EVT-99463-1krekt6 · Official record ↗

FDA Class I · Drug · August 19, 2026

Cefazolin in Dextrose recall — Baxter Healthcare Corporation

Presence of Particulate Matter

Company / brand: Baxter Healthcare recalls

Affected product: Cefazolin in Dextrose recall status

Official ID D-0787-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Optiray Imaging Bulk Package-350 recall — Liebel-Flarsheim Company LLC

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Company / brand: Liebel-Flarsheim Company recalls

Affected product: Optiray Imaging Bulk Package-350 recall status

Official ID D-0773-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Glutathione (MDV) recall — Victory Medical Center Pharmacy

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Company / brand: Victory Medical Center Pharmacy recalls

Affected product: Glutathione (MDV) recall status

Official ID D-0772-2026 · Official record ↗

FDA Class I · Drug · August 19, 2026

Kian Pee Wan Capsules recall — Buy-Herbal

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Company / brand: Buy-Herbal recalls

Affected product: Kian Pee Wan Capsules recall status

Official ID D-0769-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall — Heritage Pharmaceuticals Inc

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Company / brand: Heritage Pharmaceuticals recalls

Affected product: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall status

Official ID D-0768-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

CLEAR EYES Maximum Itchy Eye Relief recall — Prestige Brands Holdings

Lack of assurance of sterility. The recall is due to potential contamination

Company / brand: Prestige Brands Holdings recalls

Affected product: CLEAR EYES Maximum Itchy Eye Relief recall status

Official ID D-0766-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SILDENAFIL CITRATE USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Affected product: SILDENAFIL CITRATE USP recall status

Official ID D-0763-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

TADALAFIL USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Affected product: TADALAFIL USP recall status

Official ID D-0762-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

TADALAFIL USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Affected product: TADALAFIL USP recall status

Official ID D-0761-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

TADALAFIL USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Affected product: TADALAFIL USP recall status

Official ID D-0760-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SILDENAFIL CITRATE USP recall — Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

Company / brand: Shoolin Pharma Chem LLP recalls

Affected product: SILDENAFIL CITRATE USP recall status

Official ID D-0759-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 20mg (5mg/mL) recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 20mg (5mg/mL) recall status

Official ID D-0757-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 10mg (5mg/mL) recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 10mg (5mg/mL) recall status

Official ID D-0756-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 7 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 7 recall status

Official ID D-0755-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 5mg (1mg/mL) recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 5mg (1mg/mL) recall status

Official ID D-0754-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 2 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 2 recall status

Official ID D-0753-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 0 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 0 recall status

Official ID D-0752-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 9mg (4 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 9mg (4 recall status

Official ID D-0751-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 4 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 4 recall status

Official ID D-0750-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 6 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 6 recall status

Official ID D-0749-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 2 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 2 recall status

Official ID D-0748-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

SEMAGLUTIDE 12 recall — Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Company / brand: Apollo Care recalls

Affected product: SEMAGLUTIDE 12 recall status

Official ID D-0747-2026 · Official record ↗

FDA Class II · Drug · August 19, 2026

Diovan (valsartan) 160 mg recall — Novartis Pharmaceuticals Corporation

Failed Dissolution Specifications

Company / brand: Novartis Pharmaceuticals recalls

Affected product: Diovan (valsartan) 160 mg recall status

Official ID D-0746-2026 · Official record ↗

FDA Class II · Drug · August 12, 2026

Mirabegron Extended-Release Tablets recall — Zydus Pharmaceuticals (USA) Inc

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Company / brand: Zydus Pharmaceuticals (USA) recalls

Affected product: Mirabegron Extended-Release Tablets recall status

Official ID D-0745-2026 · Official record ↗

FDA Class I · Drug · August 12, 2026

Cyclophosphamide for Injection recall — Sunny Pharmtech Inc.

Presence of Particulate Matter; identified as stainless steel

Company / brand: Sunny Pharmtech recalls

Affected product: Cyclophosphamide for Injection recall status

Official ID D-0744-2026 · Official record ↗

FDA Class I · Drug · August 12, 2026

Cyclophosphamide for Injection recall — Sunny Pharmtech Inc.

Presence of Particulate Matter; identified as stainless steel

Company / brand: Sunny Pharmtech recalls

Affected product: Cyclophosphamide for Injection recall status

Official ID D-0743-2026 · Official record ↗

FDA Class III · Drug · August 12, 2026

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag recall — Central Admixture Pharmacy Services Inc

Incorrect Product Formulation

Company / brand: Central Admixture Pharmacy Services recalls

Affected product: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag recall status

Official ID D-0740-2026 · Official record ↗

FDA Class II · Drug · August 12, 2026

Dicyclomine Hydrochloride Capsules recall — Aurobindo Pharma USA Inc

shortfill; reports of empty capsules.

Company / brand: Aurobindo Pharma USA recalls

Affected product: Dicyclomine Hydrochloride Capsules recall status

Official ID D-0733-2026 · Official record ↗

FDA Not Yet Classified · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impur…

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran Etexilate Capsules recall status

Official ID EVT-99421-191x326 · Official record ↗

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran Etexilate Capsules recall status

Official ID D-0739-2026 · Official record ↗

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran Etexilate Capsules recall status

Official ID D-0738-2026 · Official record ↗

FDA Class III · Drug · August 5, 2026

Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran Etexilate Capsules recall status

Official ID D-0737-2026 · Official record ↗

FDA Class II · Drug · August 5, 2026

Mycophenolate Mofetil for Injection USP recall — MYLAN PHARMACEUTICALS INC

Presence of precipitate

Company / brand: MYLAN PHARMACEUTICALS recalls

Affected product: Mycophenolate Mofetil for Injection USP recall status

Official ID D-0734-2026 · Official record ↗

FDA Class II · Drug · August 5, 2026

Azelaic Acid Gel recall — Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Company / brand: Glenmark Pharmaceuticals recalls

Affected product: Azelaic Acid Gel recall status

Official ID D-0731-2026 · Official record ↗

FDA Class II · Drug · August 5, 2026

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall — MICRO LABS USA INC

Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Company / brand: MICRO LABS USA recalls

Affected product: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall status

Official ID D-0730-2026 · Official record ↗

FDA Not Yet Classified · Drug · July 29, 2026

Glycopyrrolate Oral Solution recall — Precision Dose Inc.

Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.

Company / brand: Precision Dose recalls

Affected product: Glycopyrrolate Oral Solution recall status

Official ID EVT-99388-g6s9bf · Official record ↗

FDA Not Yet Classified · Drug · July 29, 2026

Trokendi XR recall — Supernus Pharmaceuticals, Inc.

Failed Dissolution Specifications

Company / brand: Supernus Pharmaceuticals recalls

Affected product: Trokendi XR recall status

Official ID EVT-99375-1qlo6cy · Official record ↗

FDA Class III · Drug · July 29, 2026

Trokendi XR recall — Supernus Pharmaceuticals, Inc.

Failed Dissolution Specifications

Company / brand: Supernus Pharmaceuticals recalls

Affected product: Trokendi XR recall status

Official ID D-0758-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Divalproex Sodium Delayed-Release Tablets recall — Bionpharma Inc.

Presence of Foreign Tablets/Capsules

Company / brand: Bionpharma recalls

Affected product: Divalproex Sodium Delayed-Release Tablets recall status

Official ID D-0742-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Glycopyrrolate Oral Solution recall — Precision Dose Inc.

Failed Impurities/Degradation Specifications

Company / brand: Precision Dose recalls

Affected product: Glycopyrrolate Oral Solution recall status

Official ID D-0741-2026 · Official record ↗

FDA Class III · Drug · July 29, 2026

Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran etexilate Capsules recall status

Official ID D-0736-2026 · Official record ↗

FDA Class III · Drug · July 29, 2026

Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…

Company / brand: Ascend Laboratories recalls

Affected product: Dabigatran etexilate Capsules recall status

Official ID D-0735-2026 · Official record ↗

FDA Class I · Drug · July 29, 2026

Cetirizine Hydrochloride Tablets USP 5 mg recall — JB Chemicals and Pharmaceuticals Ltd

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to …

Company / brand: JB Chemicals and Pharmaceuticals recalls

Affected product: Cetirizine Hydrochloride Tablets USP 5 mg recall status

Official ID D-0732-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Company / brand: Fresenius Kabi USA recalls

Affected product: Xylocaine (lidocaine HCl Injection recall status

Official ID D-0729-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Company / brand: Fresenius Kabi USA recalls

Affected product: Xylocaine (lidocaine HCl Injection recall status

Official ID D-0728-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Naropin (ropivacaine hydrochloride Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Company / brand: Fresenius Kabi USA recalls

Affected product: Naropin (ropivacaine hydrochloride Injection recall status

Official ID D-0727-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Lidocaine HCl Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in products

Company / brand: Fresenius Kabi USA recalls

Affected product: Lidocaine HCl Injection recall status

Official ID D-0726-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Glycopyrrolate Injection recall — Fresenius Kabi USA, LLC

Presence of Particulate Matter: Hair was found in product

Company / brand: Fresenius Kabi USA recalls

Affected product: Glycopyrrolate Injection recall status

Official ID D-0725-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rising recall — Rising Pharma Holding, Inc.

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Company / brand: Rising Pharma Holding recalls

Affected product: Rising recall status

Official ID D-0724-2026 · Official record ↗

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Sources last checked October 22, 2026 at 12:00 PM UTC.