Home / Recalls / Amneal Pharmaceuticals, LLC / D-0408-2026

D-0408-2026 Class II Ongoing

Recalled by Amneal Pharmaceuticals, LLC — Bridgewater, NJ

Recall Details

Product Type
Drugs
Report Date
April 8, 2026
Initiation Date
March 19, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,542 bottles

Product Description

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

Reason for Recall

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

Distribution Pattern

Nationwide within the USA

Code Information

Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

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