FDA Recall D-0408-2026

Amneal Pharmaceuticals, LLC · Bridgewater, NJ

Class II Ongoing 56 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

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

Quantity: 29,542 bottles

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).

Recall record

Recall number: D-0408-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide within the USA
Recall initiated: 2026-03-19
Classified by FDA Center: 2026-03-30
FDA published: 2026-04-08
Recalling firm: Amneal Pharmaceuticals, LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): TRAMADOL HYDROCHLORIDE
Generic name(s): TRAMADOL HYDROCHLORIDE
Manufacturer(s): Amneal Pharmaceuticals NY LLC
NDC(s): 60219-2348
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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