FDAHealthMay 1, 2026
Amerisource Health Services LLC — 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
⚠️ Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 1, 2026
USA Nationwide
What's affected?
- 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
- Brand
- PRIMIDONE
- Lot code
- 1028739
Additional details
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 225,000 tablets.
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