Tramadol Hydrochloride Tablets 50 mg
Amneal is recalling 500-count bottles of Tramadol Hydrochloride 50 mg tablets due to an impurity found during stability testing.
Contact your healthcare provider or pharmacist if you have questions or concerns regarding your medication. Do not stop taking your prescribed medication without consulting your doctor.
Why it was recalled
Amneal Pharmaceuticals is recalling 500-count bottles of Tramadol Hydrochloride Tablets, 50 mg, due to the presence of N-nitroso-desmethyl-tramadol (NDSRI) impurity above specification limits. This recall was initiated following stability testing results and is distributed nationwide.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0408-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Amneal Pharmaceuticals, LLC
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification