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
Clindamycin Phosphate Topical Solution USP
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Feb 20, 2024
Clindamycin Phosphate
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Feb 20, 2024
Mercaptopurine Tablets
Class IIIFailed Dissolution Specifications: results slightly under spec at at 9-months.
Stason Pharmaceuticals, Inc. · Feb 9, 2024
HydrALAZINE Hydrochloride Tablets
Class IIIFailed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Amerisource Health Services LLC · Feb 1, 2024
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regime…
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · Jan 25, 2024
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · Jan 25, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 2024
Showing 8 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.