FDA-Drug2026-06-17Class IIICHEMICAL
Amneal Primidone tablets recalled for potential cross-contamination with Acemetacin
UNDECLARED INGREDIENTSNationwide distribution
Amneal Primidone tablets recalled for cross-contamination risk
Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.
- Contact your pharmacist or doctor if you have this medication — do not stop taking it without medical guidance.
- Check the lot number on your bottle against lot AM251676 and expiration date 11/31/2028.
- Return recalled bottles to your pharmacy or contact Amneal Pharmaceuticals for instructions.
Hazard
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Sold states
Nationwide within the USA.
Affected count
27,936 100-count bottles
Manufactured in
400 Crossing Blvd Fl 3, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0585-2026More Amneal Pharmaceuticals, LLC recalls
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