Amneal Pharmaceuticals, LLC recalls Primidone Tablets
- Recalling company
- Amneal Pharmaceuticals, LLC
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
- Reason
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 3, 2026
- Reported
- Jun 17, 2026
- Distribution
- Nationwide within the USA.
- Status
- Ongoing
- Quantity
- 27,936 100-count bottles
- Lot / codes
- Lot AM251676, EXP 11/31/2028
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0585-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0585-2026 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.