Amneal Pharmaceuticals, LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral
Recalled June 17, 2026 · FDA recall D-0585-2026 · Amneal Pharmaceuticals
Hazard
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. · FDA Class III
Units
27,936 100-count bottles
Sold at
Nationwide within the USA.
Description
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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
Manufacturer(s)
Amneal Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →