Tramadol Hydrochloride Tablets, USP 50 mg
Amneal is recalling tramadol 50 mg tablets (NDC 60219-2348-5) due to elevated N-nitroso-desmethyl-tramadol impurity.
Do not use this medication without consulting your healthcare provider or pharmacist. Contact your pharmacy with the NDC number 60219-2348-5 to verify if your tramadol tablets are affected. Your healthcare provider may recommend an alternative pain medication or a different lot of tramadol.
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).
How to identify it
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.
Where it was sold
Distributed in US.
Official source
Other recent recalls from Amneal Pharmaceuticals, LLC
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification