Primidone Tablets recall — Class III (D-0537-2026) · pharmaranks
Class IIIOngoing
Primidone Tablets recall
FDA recall D-0537-2026 · initiated May 1, 2026
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Details
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
Recalling company
Amerisource Health Services LLC
Classification
Class III
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
USA Nationwide
Initiated
May 1, 2026
FDA report date
May 27, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.