FDAMay 1, 2026drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

amerisource health servicesamerisourceamerisource health

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Details · AllClear