FDA-Drug2026-04-08Class IICHEMICAL
Amneal Pharmaceuticals tramadol 50 mg tablets recalled for elevated impurity levels
What this means
Amneal Pharmaceuticals is recalling specific lots of tramadol 50 mg tablets because they contain higher-than-allowed levels of a chemical impurity called N-nitroso-desmethyl-tramadol (NDSRI). The impurity was discovered during stability testing of tablets nearing the end of their shelf life. No injuries have been reported.
- Check if your tramadol bottle matches lot AM230987 (expires 05/2026) or AR232387 (expires 12/2026).
- If you have one of these lots, contact your pharmacy or prescriber for a replacement.
- Do not stop taking tramadol abruptly; talk to your doctor about next steps.
The agency's original wording
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).
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the USA
Affected count
29,542 bottles
Manufactured in
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2026Want us to check the next one for you?
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