Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Recall Number: D-0537-2026

Firm: Amerisource Health Services LLC

Classification: Class III

Status: Ongoing

Report Date: 20260527

Initiation Date: 20260501

Termination Date:

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11