Amneal tramadol tablets recalled for impurity out of specification
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.
From the FDA notice · Read the official notice ↗ · All Amneal Pharmaceuticals recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 29,542 bottles
- Illnesses reported
- None reported
- Manufactured in
- 400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
- Classification
- Class II
- Recall number
- D-0408-2026
In the FDA's words
- Description
- 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. 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). Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026. Distribution: Nationwide within the USA Affected quantity: 29,542 bottles
- 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).
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ModerateFDAOct 7, 2026