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.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals, LLC · Jun 3, 2026
Failed Stability Specifications
AbbVie Inc. · May 18, 2026
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Eugia US LLC · May 18, 2026
Failed Impurities/Degradations Specifications
Fresenius Kabi USA, LLC · May 14, 2026
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
AVEVA Drug Delivery Systems, Inc. · May 14, 2026
Failed Impurities/Degradation Specifications
Sagent Pharmaceuticals · May 4, 2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc. · Apr 27, 2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lannett Company Inc. · Apr 24, 2026
Labeling: Missing Label
American Regent, Inc. · Apr 16, 2026
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Premier Dental Products Co · Apr 14, 2026
Subpotent drug
Unichem Pharmaceuticals USA Inc. · Apr 13, 2026
Failed PH Specifications
Water-Jel Technologies, LLC · Apr 7, 2026
Subpotent drug
Avantor Performance Materials LLC · Mar 31, 2026
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories · Mar 18, 2026
Failed Tablet/Capsule Specifications
Radnostix · Feb 19, 2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Labeling: 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
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Annora Pharma Private Limited · Feb 3, 2026
Tablets/Capsules Imprinted with Wrong ID
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
Labeling: 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
Failed PH Specifications
Cipla USA, Inc. · Dec 22, 2025
Failed 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
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Alembic Pharmaceuticals Limited · Dec 16, 2025
Failed Impurities/Degradation Specifications
NOVADOZ PHARMACEUTICALS LLC · Dec 15, 2025
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 26, 2025
Subpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Subpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Correct 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
Subpotent product:out of specification assay results observed during long term stability testing.
SOMERSET THERAPEUTICS LLC · Nov 26, 2025
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Glenmark Pharmaceuticals Inc., USA · Nov 21, 2025
Cross Contamination with Other Products
Glenmark Pharmaceuticals Inc., USA · Nov 18, 2025
Sub 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
Defective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA, Inc · Nov 7, 2025
Showing the 40 most recent Class III recalls of 1617 tracked.
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.