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
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Cyclophosphamide for Injection
Class IIILabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
X-Gen Pharmaceuticals Inc. · Apr 2, 2024
Cyclophosphamide for Injection
Class IIILabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
X-Gen Pharmaceuticals Inc. · Apr 2, 2024
NEXLIZET (bempedoic acid and ezetimibe) tablets
Class IIIFailed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Esperion · Mar 27, 2024
Digoxin Tablets
Class IIIFailed Impurities/Degradation Specifications
Novitium Pharma LLC · Mar 25, 2024
Digoxin Tablets
Class IIICross Contamination with Other Products:(mycophenolate mofetil).
Novitium Pharma LLC · Mar 4, 2024
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…
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 16 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.