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
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
Albuterol Sulfate
Class IIIFailed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Cipla USA, Inc. · Jul 24, 2025
Fluorescein 2% Ophth
Class IIISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Class IIISub-Potent Drug: Subpotent assay results during stability testing.
Imprimis NJOF, LLC · Jul 9, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jun 26, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jun 26, 2025
Testosterone 200 mg Pellet packaged in 1mL amber vials
Class IIILabeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Qualgen, LLC · Jun 16, 2025
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jun 11, 2025
Famciclovir Tablets
Class IIIPresence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Macleods Pharmaceuticals Ltd · Jun 11, 2025
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.