← FDA ENFORCEMENT
D-0408-2026Class II

Amneal Pharmaceuticals, LLC

Recalling firm
Amneal Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2026-04-08
Distribution
Nationwide within the USA
Firm state
NJ
Product quantity
29,542 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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).

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.