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.
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 initiated: 20260319
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated