FDAFDA · Food and drugs·Recall number D-0537-2026
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
Published May 27, 2026 · Recall initiated: May 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRIMIDONE
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- USA Nationwide
- Lot
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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