Amerisource Health Services Llc: Primidone Tablets, Usp, 50 Mg, 100 Tablets (10 X 10 Unit Dose Blister) Per Carton
Primidone Tablets Recall Summary Amerisource Health Services is recalling Primidone Tablets, USP 50 mg (100 tablets per carton) distributed nationwide because the medication was contaminated with trace amounts of Acemetacin, a different drug, due to cross-contamination during manufacturing. The affected product has carton NDC 68084-202-01 and individual dose NDC 68084-202-11. This recall applies to patients who received this prescription medication across all U.S. states and Washington, D.C.
- Recalling firm
- Amerisource Health Services LLC
- 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.
- 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/d9e32ec8-9c3d-4a0c-a48a-d19138969bee