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
Agency: FDA
Recall date: 2026-06-03
Recalling firm: Amneal Pharmaceuticals LLC

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Hazard: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Severity: Class III
Distribution: Nationwide within the USA.