Why it was recalled
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Product description
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
Lot numbers, UPCs & expiration codes
Lot AM251676, EXP 11/31/2028
Where it was sold
Nationwide within the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0585-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 3, 2026
- FDA report date
- Jun 17, 2026
- Quantity
- 27,936 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0585-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99146
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot AM251676, EXP 11/31/2028
- Postal code
- 08807-2863
- Report date
- Jun 17, 2026
- Product type
- Drugs
- Recall number
- D-0585-2026
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 27,936 100-count bottles
- Reason for recall
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the USA.
- Recall initiation date
- Jun 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2026