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
Eptifibatide Injection
Class IIILabeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Slate Run Pharmaceuticals · Feb 12, 2026
Pitavastatin Tablets
Class IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited · Feb 3, 2026
Doxazosin Tablets
Class IIITablets/Capsules Imprinted with Wrong ID
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Fluocinolone Acetonide Solution Topical USP
Class IIIFailed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Haleon US Holdings LLC · Dec 26, 2025
Diclofenac Sodium Topical Gel
Class IIIFailed PH Specifications
Cipla USA, Inc. · Dec 22, 2025
traZODONE Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc · Dec 19, 2025
Fesoterodine Fumarate
Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited · Dec 16, 2025
Glycopyrrolate Oral Solution
Class IIIFailed Impurities/Degradation Specifications
NOVADOZ PHARMACEUTICALS LLC · Dec 15, 2025
Clindamycin Phosphate USP
Class IIIFailed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)
Class IIICorrect Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Winder Laboratories, LLC · Nov 26, 2025
Cisatracurium Besylate Injection USP
Class IIISubpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Class IIICross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Glenmark Pharmaceuticals Inc., USA · Nov 21, 2025
Nebivolol Tablets
Class IIICross Contamination with Other Products
Glenmark Pharmaceuticals Inc., USA · Nov 18, 2025
Varenicline Tablets
Class IIISub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Dr. Reddy's Laboratories, Inc. · Nov 11, 2025
Carton label: Testosterone Gel 1%
Class IIIDefective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA, Inc · Nov 7, 2025
Klarity-C Drops (Cyclosporine) 0.1%
Class IIISubpotent Drug
Imprimis NJOF, LLC · Oct 20, 2025
Everolimus tablets 5mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Fesoterodine Fumarate
Class IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited · Oct 10, 2025
Everolimus tablets 10 mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 2.5 mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
Everolimus tablets 7.5mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Oct 10, 2025
FentaNYL Citrate PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Hydromorphone HCL PF
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Ketamine Hydrochloride
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma, Inc. · Oct 9, 2025
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · Sep 12, 2025
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Class IIILabeling: Not Elsewhere Classified
Letco Medical LLC · Sep 12, 2025
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · Sep 12, 2025
Everolimus tablets 5mg
Class IIIFailed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Endo USA, Inc. · Sep 5, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Aug 28, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Aug 28, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Aug 28, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Aug 28, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Aug 28, 2025
Kroger 70% Isopropyl Alcohol
Class IIICross Contamination with Other Products.
Consumer Product Partners, LLC · Aug 25, 2025
TopCare Health 70% Isopropyl Alcohol
Class IIICross Contamination with Other Products.
Consumer Product Partners, LLC · Aug 25, 2025
READYPREP PVP
Class IIISubpotent drug
Medline Industries, LP · Aug 19, 2025
Sensodyne PRONAMEL (Potassium nitrate 5%
Class IIILabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Haleon US Holdings LLC · Aug 5, 2025
Showing 40 of 176 Class III recalls (1,895 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.