Drug FDA Class III Ongoing Chemical
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
Amneal Pharmaceuticals, LLC Published Jun 17, 2026
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 48/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Amneal Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
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.
Hazards
Acemetacin · primary
Affected products (1)
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
PRIMIDONE · 27,936 100-count bottles
NDC: 53746-544, 53746-545, 53746-544-01, 53746-544-10, 53746-544-05, 53746-545-01, 53746-545-10, 53746-545-05
Lot codes: AM251676
Code info: Lot AM251676, EXP 11/31/2028
Affected areas
Nationwide
Timeline
- InitiatedJun 3, 2026
- PublishedJun 17, 2026
- Recall number
- D-0585-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.