Recall: D-0537-2026

Class III - Minor Violations

Class IIIClassification

2026-05-01Initiated

OngoingStatus

Amerisource Health Services LLFirm

Product

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

Reason

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.