FDA Drug · 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

Class III · Ongoing

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Affected lots / codes — check yours against thisLot AM251676, EXP 11/31/2028

Recalling firm: Amneal Pharmaceuticals, LLC, Bridgewater, NJ
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 27,936 100-count bottles
Distribution: Nationwide within the USA.
Recall initiated: June 3, 2026
Classified: June 10, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0585-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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