Amerisource Health Services LLC recalls Primidone Tablets
- Recalling company
- 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 – not likely to cause adverse health consequences
- Recall date
- May 1, 2026
- Reported
- May 27, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 225,000 tablets
- Lot / codes
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0537-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0537-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.