FDAFDA · Food and drugs·Recall number D-0585-2026
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
Published June 17, 2026 · Recall initiated: June 3, 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: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRIMIDONE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- Nationwide within the USA.
- Lot
- Lot AM251676, EXP 11/31/2028
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.