Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,293 recalls, newest first

Class I · High risk

Acetaminophen

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

Terminated Labeling / mix-up A-S Medication Solutions LLC. D-0358-2021
Class III · Low risk

Methylprednisolone Tablets USP

Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

Terminated Labeling / mix-up Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-001-03 D-0298-2021
Class III · Low risk

Glycopyrrolate Injection

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Terminated Labeling / mix-up Accord Healthcare, Inc. NDC 16729-472-08 D-0250-2021
Class I · High risk

Cisatracurium Besylate Injection

Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium

Terminated Labeling / mix-up Meitheal Pharmaceuticals Inc NDC 71288-712-05 D-0286-2021
Class I · High risk

Benzonatate capsules

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Terminated Labeling / mix-up Calvin Scott & Company, Inc. NDC 67877-0573-05 D-1124-2022
Class III · Low risk

Benzphetamine tablets

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Terminated Labeling / mix-up Calvin Scott & Company, Inc. NDC 10702-0040-50 D-1123-2022
Class II · Moderate risk

Sulfur Ointment 10%

Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.

Terminated Labeling / mix-up DLC Laboratories, Inc D-0257-2021
Class II · Moderate risk

N-A-C

Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.

Terminated Labeling / mix-up Jarrow Formulas Inc D-0302-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-282-10 D-0048-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-281-10 D-0047-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-280-10 D-0046-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-279-10 D-0045-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-278-10 D-0044-2021
Class III · Low risk

Dextroamphetamine Saccharate

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Terminated Labeling / mix-up ANI Pharmaceuticals, Inc. NDC 43975-277-10 D-0043-2021
Class I · High risk

Smart Care HAND SANITIZER

Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches

Terminated Labeling / mix-up Ashtel Studios, INC. NDC 70108-042-01 D-0098-2021
Class III · Low risk

Nicotine Gum

Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.

Terminated Labeling / mix-up P & L Developments, LLC NDC 11822-3328-3 D-0004-2021

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