Amerisource Health Services Llc: Primidone Tablets, Usp, 250 Mg, 100 Tablets (10 X 10 Unit Dose Blister) Per Carton

Recall Summary Primidone Tablets 250 mg distributed by American Health Packaging have been recalled nationwide because the active ingredient was contaminated with trace amounts of Acemetacin (a different drug) during manufacturing. This recall affects patients across all 50 states who received this medication in blister pack cartons with the specified NDC numbers.

Recalling firm

Amerisource Health Services LLC

Product

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

Reason

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

Classification

Class III

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-01

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/6b2c3a6d-c61b-4109-aec0-da8407f16fa1