United StatestraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles (Rx only), NDC 60219-2348-5, manufactured by Amneal Pharmaceuticals Pvt. Ltd. and distributed by Amneal Pharmaceuticals LLC, lots AM230987 (exp 05/2026) and AR232387 (exp 12/2026) sold nationwide in the U.S. are affected. They were recalled because N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of specification at the 24‑month stability interval during long term stability testing.
What's being 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.
Recalling firm: Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States.
How to identify it
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
The hazard
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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)