Fresh Recalls

Drug recalls — page 2

432 recent drug recalls in our current data. Showing 201–400, newest first.

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0 recall status

Official ID D-0722-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Dry Aid (povidone 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Dry Aid (povidone 0 recall status

Official ID D-0721-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Dry Aid (povidone 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Dry Aid (povidone 0 recall status

Official ID D-0720-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Digi Eye (hypromellose 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Digi Eye (hypromellose 0 recall status

Official ID D-0719-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0 recall status

Official ID D-0718-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall status

Official ID D-0717-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall status

Official ID D-0716-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.

Lack of Assurance of Sterility

Company / brand: Rohto-Mentholatum (Vietnam) Co recalls

Affected product: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0 recall status

Official ID D-0715-2026 · Official record ↗

FDA Class III · Drug · July 29, 2026

Lidolog Kit recall — Asclemed USA Inc.

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Company / brand: Asclemed USA recalls

Affected product: Lidolog Kit recall status

Official ID D-0713-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Amlodipine and Olmesartan Medoxomil Tablets recall — Ascend Laboratories, LLC

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Company / brand: Ascend Laboratories recalls

Affected product: Amlodipine and Olmesartan Medoxomil Tablets recall status

Official ID D-0712-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0711-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0710-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0709-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0708-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0707-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0706-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0705-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0704-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0703-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0702-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0701-2026 · Official record ↗

FDA Class II · Drug · July 29, 2026

Levothyroxine Sodium Tablets recall — Major Pharmaceuticals

Subpotent Drug

Company / brand: Major Pharmaceuticals recalls

Affected product: Levothyroxine Sodium Tablets recall status

Official ID D-0700-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Clear recall status

Official ID D-0690-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0 recall — Chiesi USA, Inc.

Lack of Assurance of Sterility

Company / brand: Chiesi USA recalls

Affected product: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0 recall status

Official ID D-0689-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CAREone recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: CAREone recall status

Official ID D-0688-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

meijer recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: meijer recall status

Official ID D-0687-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Foster & Thrive recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: Foster & Thrive recall status

Official ID D-0686-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

LEADER recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: LEADER recall status

Official ID D-0685-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

GOOD NEIGHBOR PHARMACY recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: GOOD NEIGHBOR PHARMACY recall status

Official ID D-0684-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

FAMILY Wellness recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: FAMILY Wellness recall status

Official ID D-0683-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

AUDIOLOGIST'S CHOICE recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: AUDIOLOGIST'S CHOICE recall status

Official ID D-0682-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

TopCare Health recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: TopCare Health recall status

Official ID D-0681-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

QC Quality Choice recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: QC Quality Choice recall status

Official ID D-0680-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Clinere recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: Clinere recall status

Official ID D-0679-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

CVS Health recall — Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Company / brand: Bell Pharmaceuticals recalls

Affected product: CVS Health recall status

Official ID D-0678-2026 · Official record ↗

FDA Class II · Drug · July 22, 2026

Nystatin Cream USP recall — Padagis US LLC

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Company / brand: Padagis US recalls

Affected product: Nystatin Cream USP recall status

Official ID D-0677-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS recall — Shimoga Chemicals

cGMP deviations

Company / brand: Shimoga Chemicals recalls

Affected product: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS recall status

Official ID D-0691-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Azacitidine for Injection 100mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Affected product: Azacitidine for Injection 100mg/Vial recall status

Official ID D-0674-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Bortezomib for Injection 3 recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Affected product: Bortezomib for Injection 3 recall status

Official ID D-0673-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Pemetrexed for Injection 500mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Affected product: Pemetrexed for Injection 500mg/Vial recall status

Official ID D-0672-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Pemetrexed for Injection 100mg/Vial recall — Reliance Life Sciences Private Limited

Lack of Sterility Assurance

Company / brand: Reliance Life Sciences Private recalls

Affected product: Pemetrexed for Injection 100mg/Vial recall status

Official ID D-0671-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall status

Official ID D-0670-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall status

Official ID D-0669-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% recall status

Official ID D-0668-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Gasco Isopropyl Alcohol 70% recall status

Official ID D-0667-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Gasco Isopropyl Alcohol 70% recall status

Official ID D-0666-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Gasco Isopropyl Alcohol 70% recall — Gasco Industrial Corp.

Subpotent drug

Company / brand: Gasco Industrial recalls

Affected product: Gasco Isopropyl Alcohol 70% recall status

Official ID D-0665-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Methohexital Sodium recall — QuVa Pharma, Inc.

Failed Impurities/Degradation Specifications

Company / brand: QuVa Pharma recalls

Affected product: Methohexital Sodium recall status

Official ID D-0664-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall — BioMed Laboratories, LLC.

Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

Company / brand: BioMed Laboratories recalls

Affected product: Medline Remedy Specialized Silicone Cream (Hydraguard-D ) recall status

Official ID D-0663-2026 · Official record ↗

FDA Class II · Drug · July 15, 2026

Methohexital Sodium for Injection recall — ONESOURCE SPECIALTY PHARMA LIMITED

Failed Impurities/Degradation Specifications

Company / brand: ONESOURCE SPECIALTY PHARMA recalls

Affected product: Methohexital Sodium for Injection recall status

Official ID D-0662-2026 · Official record ↗

FDA Not Yet Classified · Drug · July 8, 2026

Glucagon Emergency Kit for Low Blood Sugar recall — Lupin Pharmaceuticals Inc.

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Company / brand: Lupin Pharmaceuticals recalls

Affected product: Glucagon Emergency Kit for Low Blood Sugar recall status

Official ID EVT-99296-c9qbin · Official record ↗

FDA Class II · Drug · July 8, 2026

Glucagon Emergency Kit for Low Blood Sugar recall — Lupin Pharmaceuticals Inc.

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Company / brand: Lupin Pharmaceuticals recalls

Affected product: Glucagon Emergency Kit for Low Blood Sugar recall status

Official ID D-0723-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Gemcitabine Injection recall — McKesson

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Company / brand: McKesson recalls

Affected product: Gemcitabine Injection recall status

Official ID D-0714-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Revitaderm Wound Care recall — Blaine Labs Inc

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Company / brand: Blaine Labs recalls

Affected product: Revitaderm Wound Care recall status

Official ID D-0699-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Fungal Fusion ERADICATION Solution recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Affected product: Fungal Fusion ERADICATION Solution recall status

Official ID D-0698-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TERPENICOL Antifungal Solution recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Affected product: TERPENICOL Antifungal Solution recall status

Official ID D-0697-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

vite20 Antifungal Cream recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Affected product: vite20 Antifungal Cream recall status

Official ID D-0696-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Affected product: TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall status

Official ID D-0695-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) recall — Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Company / brand: Blaine Labs recalls

Affected product: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) recall status

Official ID D-0694-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel recall — Blaine Labs Inc

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

Company / brand: Blaine Labs recalls

Affected product: TRIFLUENT PHARMA TRIDERGEL Wound Care Gel recall status

Official ID D-0693-2026 · Official record ↗

FDA Class I · Drug · July 8, 2026

Revitaderm Wound Care Gel recall — Blaine Labs Inc

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Company / brand: Blaine Labs recalls

Affected product: Revitaderm Wound Care Gel recall status

Official ID D-0692-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Affected product: Cinacalcet Hydrochloride Tablets recall status

Official ID D-0676-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Affected product: Cinacalcet Hydrochloride Tablets recall status

Official ID D-0675-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Cinacalcet Hydrochloride Tablets recall — Cipla USA, Inc.

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Company / brand: Cipla USA recalls

Affected product: Cinacalcet Hydrochloride Tablets recall status

Official ID D-0661-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Dextroamphetamine Saccharate recall — Lannett Company Inc.

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Company / brand: Lannett Company recalls

Affected product: Dextroamphetamine Saccharate recall status

Official ID D-0660-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Lidocaine HCl Injection USP recall — Asclemed USA Inc.

Lack of Assurance of Sterility

Company / brand: Asclemed USA recalls

Affected product: Lidocaine HCl Injection USP recall status

Official ID D-0659-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Accucaine recall — Asclemed USA Inc.

Lack of Assurance of Sterility

Company / brand: Asclemed USA recalls

Affected product: Accucaine recall status

Official ID D-0658-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall — Boehringer Ingelheim Pharmaceuticals, Inc.

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

Company / brand: Boehringer Ingelheim Pharmaceuticals recalls

Affected product: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets) recall status

Official ID D-0657-2026 · Official record ↗

FDA Class II · Drug · July 8, 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-0656-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

prednisoLONE Acetate Ophthalmic Suspension recall — Lupin Pharmaceuticals Inc.

Presence of Foreign Substance

Company / brand: Lupin Pharmaceuticals recalls

Affected product: prednisoLONE Acetate Ophthalmic Suspension recall status

Official ID D-0655-2026 · Official record ↗

FDA Class III · Drug · July 8, 2026

Fexofenadine Hydrochloride Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Fexofenadine Hydrochloride Tablets recall status

Official ID D-0654-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

IMULDOSA recall — ACCORD BIOPHARMA INC

Lack of assurance of Sterility:

Company / brand: ACCORD BIOPHARMA recalls

Affected product: IMULDOSA recall status

Official ID D-0653-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep CLear recall status

Official ID D-0652-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep CLear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep CLear recall status

Official ID D-0651-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Scrub Teal recall status

Official ID D-0650-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Scrub Teal recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Scrub Teal recall status

Official ID D-0649-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Hi-Lite Orange recall status

Official ID D-0648-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Hi-Lite Orange recall status

Official ID D-0647-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

ChloraPrep FREPP recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: ChloraPrep FREPP recall status

Official ID D-0646-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Clear recall status

Official ID D-0645-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD PurPrep recall status

Official ID D-0644-2026 · Official record ↗

FDA Class II · Drug · July 8, 2026

BD ChloraPrep Hi-Lite Orange recall — CareFusion 213, LLC

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of th…

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Hi-Lite Orange recall status

Official ID D-0643-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Perampanel CIII Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Perampanel CIII Tablets recall status

Official ID D-0628-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Povi-One recall — Elevate Oral Care

sub potency

Company / brand: Elevate Oral Care recalls

Affected product: Povi-One recall status

Official ID D-0627-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Lacosamide Tablets recall — Annora Pharma Private Limited

Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

Company / brand: Annora Pharma Private recalls

Affected product: Lacosamide Tablets recall status

Official ID D-0626-2026 · Official record ↗

FDA Class I · Drug · July 1, 2026

BD ChloraPrep FREPP Clear recall — CareFusion 213, LLC

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep FREPP Clear recall status

Official ID D-0625-2026 · Official record ↗

FDA Class I · Drug · July 1, 2026

BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I recall — CareFusion 213, LLC

Non-Sterility: Due to presence of Aspergillus penicillioides.

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (I recall status

Official ID D-0624-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

BD ChloraPrep FREPP Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep FREPP Clear recall status

Official ID D-0623-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

BD ChloraPrep Clear recall — CareFusion 213, LLC

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Company / brand: CareFusion 213 recalls

Affected product: BD ChloraPrep Clear recall status

Official ID D-0622-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

PReye Vitamin See Antioxidant Preservative Free Eye Drops recall — PReye LLC

Lack of Assurance of Sterility

Company / brand: PReye recalls

Affected product: PReye Vitamin See Antioxidant Preservative Free Eye Drops recall status

Official ID D-0621-2026 · Official record ↗

FDA Class III · Drug · July 1, 2026

hydrOXYzine Hydrochloride Oral Solution recall — ANI Pharmaceuticals, Inc.

Presence of foreign substance

Company / brand: ANI Pharmaceuticals recalls

Affected product: hydrOXYzine Hydrochloride Oral Solution recall status

Official ID D-0619-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

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

Incorrect product formulation: bag did not contain copper and famotidine per label.

Company / brand: Central Admixture Pharmacy Services recalls

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

Official ID D-0618-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

DULOXETINE D/R recall — Direct Rx

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Company / brand: Direct Rx recalls

Affected product: DULOXETINE D/R recall status

Official ID D-0617-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Company / brand: Amgen recalls

Affected product: Sensipar (cinacalcet) Tablets recall status

Official ID D-0616-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Corlanor (ivabradine) tablets recall — Amgen, Inc.

Presence of Foreign Substance.

Company / brand: Amgen recalls

Affected product: Corlanor (ivabradine) tablets recall status

Official ID D-0615-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Company / brand: Amgen recalls

Affected product: Sensipar (cinacalcet) Tablets recall status

Official ID D-0614-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Sensipar (cinacalcet) Tablets recall — Amgen, Inc.

CGMP Deviations

Company / brand: Amgen recalls

Affected product: Sensipar (cinacalcet) Tablets recall status

Official ID D-0613-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Corlanor (ivabradine) tablets recall — Amgen, Inc.

Presence of Foreign Substance.

Company / brand: Amgen recalls

Affected product: Corlanor (ivabradine) tablets recall status

Official ID D-0612-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Fenofibrate Capsules recall — Ajanta Pharma USA Inc

CGMP Deviations

Company / brand: Ajanta Pharma USA recalls

Affected product: Fenofibrate Capsules recall status

Official ID D-0611-2026 · Official record ↗

FDA Class II · Drug · July 1, 2026

Carton Label recall — The Harvard Drug Group LLC

Subpotent Drug

Company / brand: The Harvard Drug Group recalls

Affected product: Carton Label recall status

Official ID D-0609-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0642-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0641-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0640-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0639-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0638-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0637-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0636-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Med Pride recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Med Pride recall status

Official ID D-0635-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Cura Hongos recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Cura Hongos recall status

Official ID D-0634-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Rapidol recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Rapidol recall status

Official ID D-0633-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lil Drug Store recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Lil Drug Store recall status

Official ID D-0632-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Circle K recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Circle K recall status

Official ID D-0631-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lucky Super Soft recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Lucky Super Soft recall status

Official ID D-0630-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Lucky Super Soft recall — Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

Company / brand: Dabur India recalls

Affected product: Lucky Super Soft recall status

Official ID D-0629-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Chlorthalidone Tablets recall — Inventia Healthcare Limited

Failed Dissolution Specifications

Company / brand: Inventia Healthcare recalls

Affected product: Chlorthalidone Tablets recall status

Official ID D-0610-2026 · Official record ↗

FDA Class III · Drug · June 24, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg recall — Sandoz Inc

Labeling: Incorrect or Missing Lot and/or Exp Date

Company / brand: Sandoz recalls

Affected product: Focalin XR (dexmethylphenidate HCl) 5 mg recall status

Official ID D-0608-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

safco SensiCaine-Ultra (20% Benzocaine) recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: safco SensiCaine-Ultra (20% Benzocaine) recall status

Official ID D-0606-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

PureLife recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: PureLife recall status

Official ID D-0605-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Dental City TOPICAL ANESTHETIC GEL recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: Dental City TOPICAL ANESTHETIC GEL recall status

Official ID D-0604-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Burkhart topical anesthetic gel recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: Burkhart topical anesthetic gel recall status

Official ID D-0603-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

DHP Topical Anesthetic Gel recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: DHP Topical Anesthetic Gel recall status

Official ID D-0602-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Quala Dental Products recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: Quala Dental Products recall status

Official ID D-0601-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recall — Keystone Industries

Defective container:may contain bottles with incomplete seals

Company / brand: Keystone Industries recalls

Affected product: Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recall status

Official ID D-0600-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Buprenorphine HCl recall — Par Health USA, LLC

Crystallization; identified as Buprenorphine free base

Company / brand: Par Health USA recalls

Affected product: Buprenorphine HCl recall status

Official ID D-0596-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Aripiprazole Tablets USP recall — Ajanta Pharma USA Inc

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Company / brand: Ajanta Pharma USA recalls

Affected product: Aripiprazole Tablets USP recall status

Official ID D-0594-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Vasopressin 2 Units/2 mL in 0 recall — IntegraDose Compounding Services LLC

Subpotent Drug

Company / brand: IntegraDose Compounding Services recalls

Affected product: Vasopressin 2 Units/2 mL in 0 recall status

Official ID D-0593-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Company / brand: PAI Holdings recalls

Affected product: VistaPharm recall status

Official ID D-0592-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Company / brand: PAI Holdings recalls

Affected product: VistaPharm recall status

Official ID D-0591-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Company / brand: PAI Holdings recalls

Affected product: VistaPharm recall status

Official ID D-0590-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

VistaPharm recall — PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

Company / brand: PAI Holdings recalls

Affected product: VistaPharm recall status

Official ID D-0589-2026 · Official record ↗

FDA Class II · Drug · June 24, 2026

Alyacen 7/7/7 recall — Glenmark Pharmaceuticals Inc., USA

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Company / brand: Glenmark Pharmaceuticals recalls

Affected product: Alyacen 7/7/7 recall status

Official ID D-0588-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

BEEKEEPER'S NATURALS Saline Nasal Spray recall — BEEKEEPER'S NATURALS USA INC.

Microbial Contamination of Non-Sterile Products

Company / brand: BEEKEEPER'S NATURALS USA recalls

Affected product: BEEKEEPER'S NATURALS Saline Nasal Spray recall status

Official ID D-0620-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Budesonide Inhalation Suspension recall — SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Budesonide Inhalation Suspension recall status

Official ID D-0607-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Minocycline Hydrochloride Extended-Release Tablets recall — Ascend Laboratories, LLC

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

Company / brand: Ascend Laboratories recalls

Affected product: Minocycline Hydrochloride Extended-Release Tablets recall status

Official ID D-0597-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

Gas-X Extra Strength recall — Haleon US Holdings LLC

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Company / brand: Haleon US Holdings recalls

Affected product: Gas-X Extra Strength recall status

Official ID D-0595-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

GSMS Incorporated recall — Golden State Medical Supply Inc.

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

Company / brand: Golden State Medical Supply recalls

Affected product: GSMS Incorporated recall status

Official ID D-0587-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Zep recall — Zep Inc

Microbial contamination of sterile products

Company / brand: Zep recalls

Affected product: Zep recall status

Official ID D-0586-2026 · Official record ↗

FDA Class III · Drug · June 17, 2026

Primidone Tablets recall — Amneal Pharmaceuticals, LLC

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Company / brand: Amneal Pharmaceuticals recalls

Affected product: Primidone Tablets recall status

Official ID D-0585-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Duloxetine Delayed-Release Capsules recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Company / brand: Breckenridge Pharmaceutical recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0583-2026 · Official record ↗

FDA Class II · Drug · June 17, 2026

Duloxetine Delayed-Release Capsules recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Company / brand: Breckenridge Pharmaceutical recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0582-2026 · Official record ↗

FDA Class III · Drug · June 17, 2026

Epinephrine Injection recall — Fresenius Kabi USA, LLC

Failed Impurities/Degradations Specifications

Company / brand: Fresenius Kabi USA recalls

Affected product: Epinephrine Injection recall status

Official ID D-0581-2026 · Official record ↗

FDA Class I · Drug · June 17, 2026

DOXOrubin Hydrochloride Liposome injection recall — SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Particulate matter: Particulate matter identified as glass.

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: DOXOrubin Hydrochloride Liposome injection recall status

Official ID D-0580-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Xyvona (levorphanol tartrate tablets) recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Xyvona (levorphanol tartrate tablets) recall status

Official ID D-0599-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Xyvona (levorphanol tartrate tablets) recall — SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Company / brand: SUN PHARMACEUTICAL INDUSTRIES recalls

Affected product: Xyvona (levorphanol tartrate tablets) recall status

Official ID D-0598-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Niacin Extended-release Tablets recall — Lannett Company Inc.

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Company / brand: Lannett Company recalls

Affected product: Niacin Extended-release Tablets recall status

Official ID D-0584-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

TopCare health recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: TopCare health recall status

Official ID D-0579-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

TopCare health recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: TopCare health recall status

Official ID D-0578-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

EQUALINE ultra strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: EQUALINE ultra strength recall status

Official ID D-0577-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

EQUALINE extra strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: EQUALINE extra strength recall status

Official ID D-0576-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

GOODSENSE Ultra Strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: GOODSENSE Ultra Strength recall status

Official ID D-0575-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

GOODSENSE Extra Strength recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: GOODSENSE Extra Strength recall status

Official ID D-0574-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

H recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: H recall status

Official ID D-0573-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HyVee recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: HyVee recall status

Official ID D-0572-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HyVee recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: HyVee recall status

Official ID D-0571-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Harris Teeter recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: Harris Teeter recall status

Official ID D-0570-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

FAMILY WELLNESS recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: FAMILY WELLNESS recall status

Official ID D-0569-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

FAMILY WELLNESS recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: FAMILY WELLNESS recall status

Official ID D-0568-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

DISCOUNT drug mart recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: DISCOUNT drug mart recall status

Official ID D-0567-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

CAREone recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: CAREone recall status

Official ID D-0566-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

CAREone recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: CAREone recall status

Official ID D-0565-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

MARKET BASKET ANTACID Calcium Carbonate 1000 mg recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: MARKET BASKET ANTACID Calcium Carbonate 1000 mg recall status

Official ID D-0564-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

24/7 life BY 7-ELEVEN recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: 24/7 life BY 7-ELEVEN recall status

Official ID D-0563-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Extra strength Antacid Calcium Carbonate 750 mg recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: Extra strength Antacid Calcium Carbonate 750 mg recall status

Official ID D-0562-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Good Neighbor Pharmacy recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: Good Neighbor Pharmacy recall status

Official ID D-0561-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Good Neighbor Pharmacy recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: Good Neighbor Pharmacy recall status

Official ID D-0560-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HALEON CALCIUM CARBONATE TUMS ANTACID recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: HALEON CALCIUM CARBONATE TUMS ANTACID recall status

Official ID D-0559-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

HALEON CALCIUM CARBONATE TUMS ANTACID recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: HALEON CALCIUM CARBONATE TUMS ANTACID recall status

Official ID D-0558-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

KIRKLAND Signature recall — Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

Company / brand: Guardian Drug Co recalls

Affected product: KIRKLAND Signature recall status

Official ID D-0557-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Amlodipine and Olmesartan Medoxomil Tablets recall — Ascend Laboratories, LLC

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Company / brand: Ascend Laboratories recalls

Affected product: Amlodipine and Olmesartan Medoxomil Tablets recall status

Official ID D-0556-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Duloxetine DR Capsules recall — Asclemed USA Inc.

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Company / brand: Asclemed USA recalls

Affected product: Duloxetine DR Capsules recall status

Official ID D-0555-2026 · Official record ↗

FDA Class II · Drug · June 10, 2026

Lidocaine HCl Injection USP recall — Spectra Medical Devices, Llc

Lack of Assurance of Sterility

Company / brand: Spectra Medical Devices recalls

Affected product: Lidocaine HCl Injection USP recall status

Official ID D-0554-2026 · Official record ↗

FDA Class III · Drug · June 10, 2026

Lidocaine HCl Injection recall — Eugia US LLC

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Company / brand: Eugia US recalls

Affected product: Lidocaine HCl Injection recall status

Official ID D-0552-2026 · Official record ↗

FDA Class III · Drug · June 3, 2026

PRED MILD recall — AbbVie Inc.

Failed Stability Specifications

Company / brand: AbbVie recalls

Affected product: PRED MILD recall status

Official ID D-0551-2026 · Official record ↗

FDA Class III · Drug · June 3, 2026

Nicotine Transdermal System Patch recall — AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Company / brand: AVEVA Drug Delivery Systems recalls

Affected product: Nicotine Transdermal System Patch recall status

Official ID D-0550-2026 · Official record ↗

FDA Class I · Drug · May 27, 2026

MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) recall — Wisconsin Pharmacal Company

Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.

Company / brand: Wisconsin Pharmacal Company recalls

Affected product: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) recall status

Official ID D-0553-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Vitamin B-Complex recall — Safecor Health, LLC

Presence of a Foreign Substance; black particles observed in liquid

Company / brand: Safecor Health recalls

Affected product: Vitamin B-Complex recall status

Official ID D-0549-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

fentaNYL Citrate recall — IntegraDose Compounding Services LLC

Subpotent Drug

Company / brand: IntegraDose Compounding Services recalls

Affected product: fentaNYL Citrate recall status

Official ID D-0548-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

cimzia (certolizumab pegol) recall — UCB Biosciences Inc.

Lack of Assurance of Sterility

Company / brand: UCB Biosciences recalls

Affected product: cimzia (certolizumab pegol) recall status

Official ID D-0546-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Erythromycin Tablets recall — Zydus Pharmaceuticals (USA) Inc

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Company / brand: Zydus Pharmaceuticals (USA) recalls

Affected product: Erythromycin Tablets recall status

Official ID D-0545-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Erythromycin Tablets recall — Zydus Pharmaceuticals (USA) Inc

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Company / brand: Zydus Pharmaceuticals (USA) recalls

Affected product: Erythromycin Tablets recall status

Official ID D-0544-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Estradiol Gel recall — ANI Pharmaceuticals, Inc.

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

Company / brand: ANI Pharmaceuticals recalls

Affected product: Estradiol Gel recall status

Official ID D-0543-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Gas-X recall — Haleon US Holdings LLC

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Company / brand: Haleon US Holdings recalls

Affected product: Gas-X recall status

Official ID D-0542-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Liraglutide Injection recall — Lupin Pharmaceuticals Inc.

Presence of particulate matter: a white thread-like structure in the cartridge

Company / brand: Lupin Pharmaceuticals recalls

Affected product: Liraglutide Injection recall status

Official ID D-0541-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Busulfan Injection recall — Sagent Pharmaceuticals

Failed Impurities/Degradation Specifications

Company / brand: Sagent Pharmaceuticals recalls

Affected product: Busulfan Injection recall status

Official ID D-0539-2026 · Official record ↗

FDA Class II · Drug · May 27, 2026

Atomoxetine Capsules HCL recall — Safecor Health, LLC

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Company / brand: Safecor Health recalls

Affected product: Atomoxetine Capsules HCL recall status

Official ID D-0538-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Company / brand: Amerisource Health Services recalls

Affected product: Primidone Tablets recall status

Official ID D-0537-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Company / brand: Amerisource Health Services recalls

Affected product: Primidone Tablets recall status

Official ID D-0536-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Company / brand: Golden State Medical Supply recalls

Affected product: Primidone Tablets recall status

Official ID D-0535-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets recall — Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Company / brand: Golden State Medical Supply recalls

Affected product: Primidone Tablets recall status

Official ID D-0534-2026 · Official record ↗

FDA Class III · Drug · May 27, 2026

Primidone Tablets USP recall — Lannett Company Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Company / brand: Lannett Company recalls

Affected product: Primidone Tablets USP recall status

Official ID D-0533-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Ascend Laboratories recall — Ascend Laboratories, LLC

Failed Dissolution Specifications

Company / brand: Ascend Laboratories recalls

Affected product: Ascend Laboratories recall status

Official ID D-0547-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Buprenorphine Hydrochloride recall — ENDO USA, Inc.

Crystallization; identified as Buprenorphine free base

Company / brand: ENDO USA recalls

Affected product: Buprenorphine Hydrochloride recall status

Official ID D-0527-2026 · Official record ↗

FDA Class II · Drug · May 20, 2026

Oasis Tears PF recall — Oasis Medical, Inc.

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

Company / brand: Oasis Medical recalls

Affected product: Oasis Tears PF recall status

Official ID D-0525-2026 · Official record ↗

FDA Class I · Drug · May 13, 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-0540-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

TPN bag (patient specific) recall — Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Incorrect Product Formulation: product did not contain insulin as listed in the label.

Company / brand: Central Admixture Pharmacy Services recalls

Affected product: TPN bag (patient specific) recall status

Official ID D-0524-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

NAPROXEN ORAL SUSPENSION recall — Acella Pharmaceuticals, LLC

Chemical contamination; presence of lead and lithium above specification

Company / brand: Acella Pharmaceuticals recalls

Affected product: NAPROXEN ORAL SUSPENSION recall status

Official ID D-0523-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules USP recall — Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Company / brand: Breckenridge Pharmaceutical recalls

Affected product: Duloxetine Delayed-Release Capsules USP recall status

Official ID D-0522-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Enalapril Maleate Tablets recall — JB Chemicals and Pharmaceuticals Ltd

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

Company / brand: JB Chemicals and Pharmaceuticals recalls

Affected product: Enalapril Maleate Tablets recall status

Official ID D-0520-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Octreotide Acetate for Injectable Suspension recall — Teva Pharmaceuticals USA, Inc

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Company / brand: Teva Pharmaceuticals USA recalls

Affected product: Octreotide Acetate for Injectable Suspension recall status

Official ID D-0519-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

BD PurPrep recall — CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

Company / brand: CareFusion 213 recalls

Affected product: BD PurPrep recall status

Official ID D-0518-2026 · Official record ↗

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