Fresh Recalls

Drug recalls — page 3

432 recent drug recalls in our current data. Showing 401–432, newest first.

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-0517-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0516-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0515-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0514-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Company / brand: Fresenius Medical Care Holdings recalls

Affected product: DELFLEX recall status

Official ID D-0513-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Company / brand: Fresenius Medical Care Holdings recalls

Affected product: DELFLEX recall status

Official ID D-0512-2026 · Official record ↗

FDA Class III · Drug · May 13, 2026

busPIRone Hydrochloride Tablets recall — Unichem Pharmaceuticals USA Inc.

Subpotent drug

Company / brand: Unichem Pharmaceuticals USA recalls

Affected product: busPIRone Hydrochloride Tablets recall status

Official ID D-0511-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Alendronate Sodium Oral Solution recall — Hikma Pharmaceuticals USA INC

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Company / brand: Hikma Pharmaceuticals USA recalls

Affected product: Alendronate Sodium Oral Solution recall status

Official ID D-0526-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Lidocaine Wound Gel (Benzalkonium Chloride recall — Water-Jel Technologies, LLC

Failed PH Specifications

Company / brand: Water-Jel Technologies recalls

Affected product: Lidocaine Wound Gel (Benzalkonium Chloride recall status

Official ID D-0509-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: fentaNYL Citrate Injectable Solution in 0 recall status

Official ID D-0508-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Ketamine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: Ketamine Hydrochloride Injectable Solution recall status

Official ID D-0507-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: fentaNYL Citrate Injectable Solution in 0 recall status

Official ID D-0506-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: fentaNYL Citrate Injectable Solution recall status

Official ID D-0505-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate injectable Solution in 0 recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: fentaNYL Citrate injectable Solution in 0 recall status

Official ID D-0504-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

fentaNYL Citrate Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: fentaNYL Citrate Injectable Solution recall status

Official ID D-0503-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Phenylephrine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC

cGMP deviations.

Company / brand: Wells Pharma of Houston recalls

Affected product: Phenylephrine Hydrochloride Injectable Solution recall status

Official ID D-0502-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Similasan recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Company / brand: Thea Pharma recalls

Affected product: Similasan recall status

Official ID D-0501-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

iVIZIA recall — Thea Pharma, Inc.

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Company / brand: Thea Pharma recalls

Affected product: iVIZIA recall status

Official ID D-0500-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Optase Dry Eye Intense Drops (Glycerin 0 recall — SCOPE HEALTH

Lack of Assurance of Sterility

Company / brand: SCOPE HEALTH recalls

Affected product: Optase Dry Eye Intense Drops (Glycerin 0 recall status

Official ID D-0499-2026 · Official record ↗

FDA Class III · Drug · May 6, 2026

Levocarnitine Injection recall — American Regent, Inc.

Labeling: Missing Label

Company / brand: American Regent recalls

Affected product: Levocarnitine Injection recall status

Official ID D-0494-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

GenTeal Tears recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Company / brand: Alcon Research recalls

Affected product: GenTeal Tears recall status

Official ID D-0492-2026 · Official record ↗

FDA Class II · Drug · May 6, 2026

Systane recall — Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Company / brand: Alcon Research recalls

Affected product: Systane recall status

Official ID D-0491-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Claravis (isotretinoin capsule recall — Teva Pharmaceuticals USA, Inc

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Company / brand: Teva Pharmaceuticals USA recalls

Affected product: Claravis (isotretinoin capsule recall status

Official ID D-0521-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

LACTATED RINGER'S IRRIGATION recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Company / brand: B BRAUN MEDICAL recalls

Affected product: LACTATED RINGER'S IRRIGATION recall status

Official ID D-0498-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

0 recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Company / brand: B BRAUN MEDICAL recalls

Affected product: 0 recall status

Official ID D-0497-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

DEXTROSE INJECTION USP recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Company / brand: B BRAUN MEDICAL recalls

Affected product: DEXTROSE INJECTION USP recall status

Official ID D-0496-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Sterile Water for Injection USP recall — B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Company / brand: B BRAUN MEDICAL recalls

Affected product: Sterile Water for Injection USP recall status

Official ID D-0495-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Omega-3-Acid recall — The Harvard Drug Group LLC

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Company / brand: The Harvard Drug Group recalls

Affected product: Omega-3-Acid recall status

Official ID D-0493-2026 · Official record ↗

FDA Class III · Drug · April 29, 2026

Premier recall — Premier Dental Products Co

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to n…

Company / brand: Premier Dental Products Co recalls

Affected product: Premier recall status

Official ID D-0490-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

FRESHKOTE LUBRICANT EYEDROPS recall — Harrow Eye LLC

Lack of Assurance of Sterility

Company / brand: Harrow Eye recalls

Affected product: FRESHKOTE LUBRICANT EYEDROPS recall status

Official ID D-0489-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Furosemide Tablets recall — Leading Pharma, LLC

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Company / brand: Leading Pharma recalls

Affected product: Furosemide Tablets recall status

Official ID D-0486-2026 · Official record ↗

FDA Class II · Drug · April 29, 2026

Pantoprazole Sodium recall — Hetero Labs Limited (Unit V)

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Company / brand: Hetero Labs (Unit V) recalls

Affected product: Pantoprazole Sodium recall status

Official ID D-0484-2026 · Official record ↗

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