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
Venlafaxine Tablets
Class IIPresence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Zydus Pharmaceuticals (USA) Inc · Mar 21, 2025
Haloperidol Decanoate Injection 50mg/mL
Class IILack of Assurance of Sterility: Media fill with bacterial contamination
Somerset Therapeutics Private Limited · Mar 21, 2025
Atorvastatin Calcium Tablets USP 40 mg
Class IIFailed dissolution specifications: lower than specifications
BIOCON PHARMA INC · Mar 17, 2025
Fluphenazine Hydrochloride Tablets 2.5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Teriflunomide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Solifenacin Succinate Tablets 10MG
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Voriconazole Tablets 200 mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules 225mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Nitroglycerin Sublingual Tablets 0.3MG
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Clindamycin Hydrochloride Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Indomethacin Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Rosuvastatin Tablets 40mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Fluphenazine Hydrochloride Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets 200mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets 80mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Rufinamide Tablets 200mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules USP
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Carvedilol Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Acetaminophen and Ibuprofen (NSAID) Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Saxagliptin Tablets 5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Colesvelam Hydrocholoride Tablets 625mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Voriconazole Tablets 50mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Propafenone Hydrochloride Extended-Release Capsules 325mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Lacosamide Tablets 150mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Saxagliptin Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Prochlorperazine Maleate Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Gabapentin Tablets 600mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Solifenacin Succinate Tablets 5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Metformin Hydrochloride Extended-Release Tablets 1000mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Naproxen Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Frovatriptan Succinate Tablets 2.5mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Fenofibrate Capsules 67 mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Pravastatin Sodium Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Showing 40 of 1,472 Class II 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.