Home / Recalls / Amneal Pharmaceuticals, LLC / D-0585-2026

D-0585-2026 Class III Ongoing

Recalled by Amneal Pharmaceuticals, LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
June 17, 2026
Initiation Date
June 3, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,936 100-count bottles

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

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.

Distribution Pattern

Nationwide within the USA.

Code Information

Lot AM251676, EXP 11/31/2028

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