FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jun 11, 2025
Levothyroxine Sodium Tablets
Class IIIPresence of a foreign substance: black hair found embedded in tablet.
Macleods Pharmaceuticals Ltd · May 29, 2025
Ezetimibe and Simvastatin Tablets
Class IIIFailed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Glenmark Pharmaceuticals Inc., USA · May 19, 2025
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)
Class IIISuperpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
OurPharma LLC · Apr 15, 2025
Gabapentin Capsules
Class IIICross Contamination
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2025
Tolterodine Tartrate Extended-Release Capsules
Class IIIFailed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Mar 4, 2025
Gabapentin Capsules
Class IIICross Contamination
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2025
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti…
Class IIISub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Imprimis NJOF, LLC · Feb 24, 2025
Livalo (pitavatstatin) tablets
Class IIIPresence of foreign tablets/capsules
Kowa Pharmaceuticals America · Feb 24, 2025
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc…
Class IIILabeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
The W.S. Badger Company, Inc. · Jan 17, 2025
Venlafaxine Extended-Release Tablets
Class IIIFailed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Appco Pharma LLC · Jan 16, 2025
Guaifenesin and Codeine Phosphate Oral Solution USP
Class IIISuperpotent; sodium benzoate preservative
PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Jan 7, 2025
Methadone Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
West-Ward Columbus Inc · Dec 19, 2024
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey…
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
Atropine Sulfate Ophthalmic Solution
Class IIIFailed Impurities/Degradation Specifications
SOMERSET THERAPEUTICS LLC · Dec 16, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen Regular Strength
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 50 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Javygtor (sapropterin dihydrochloride) Tablets 100mg
Class IIIFailed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc. · Nov 22, 2024
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Class IIILabeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals (USA) Inc · Nov 14, 2024
Hydralazine HCl Tablets
Class IIIFailed Impurities/Degradation Specifications; during routine stability testing for impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Nov 5, 2024
IBU (ibuprofen) 600 mg tablets
Class IIIFailed Tablet/Capsule Specifications
Dr. Reddy's Laboratories, Inc. · Oct 29, 2024
Triamcinolone Acetonide Cream USP
Class IIISubpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Padagis US LLC · Oct 11, 2024
Ciclopirox Gel 0.77%
Class IIIDefective Container: Firm received complaints of broken tube at the seal.
Glenmark Pharmaceuticals Inc., USA · Sep 30, 2024
Kids' Cough and Chest Congestion (Dextromethorphan HBr
Class IIICrystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Denison Pharmaceuticals, LLC · Sep 25, 2024
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg
Class IIICrystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Denison Pharmaceuticals, LLC · Sep 25, 2024
AcetaZOLAMIDE Tablets
Class IIIDiscoloration
Rubicon Research Private Limited · Aug 24, 2024
Just Right 5000
Class IIILABELING: LABEL MIX-UP.
Elevate Oral Care · Aug 20, 2024
Varithena (polidocanol injectable foam) Administration Pack
Class IIIDefective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Biocompatibles UK, Ltd. · Aug 15, 2024
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Class IIIFailed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Taro Pharmaceuticals U.S.A., Inc. · Aug 7, 2024
Methotrexate Tablets
Class IIIPresence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Amneal Pharmaceuticals, LLC · Aug 1, 2024
Acetaminophen
Class IIILabel mix-up: Carton incorrectly labeled.
Granules Consumer Health Inc. · Jul 18, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,…
Class IIIDefective container: potential for non-sealed pouches which can lead to product leakage.
Novel Laboratories, Inc. d.b.a Lupin Somerset · Jul 2, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Showing 40 of 168 Class III recalls (1,769 tracked in total).
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.