Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt…

Recall date

March 19, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0408-2026

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals, LLC

Sold / distributed

Nationwide within the USA

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.