Amneal Pharmaceuticals, Llc: Primidone Tablets, Usp, 50 Mg, 100 Tablets Per Bottle
Recall Summary Amneal Pharmaceuticals is recalling Primidone Tablets (50 mg, 100-tablet bottles) distributed nationwide because the medication may be contaminated with Acemetacin, a different drug substance, due to a manufacturing issue at the API supplier. This is a Class III recall affecting all U.S. states and Washington, DC.
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
- Reason
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-03
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the USA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/ccf610ce-60f8-4c31-92d7-a5284eff4252