Product: TRAMADOL HYDROCHLORIDE Classification: Class II 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. Recalling firm: Amneal Pharmaceuticals, LLC Product type: Drugs
FDA MedWatch published a clinical safety alert in Pharmacology on 08 Apr 2026.
The item focuses on TRAMADOL HYDROCHLORIDE: Class II recall update.
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