FDA recall, , Moderate risk
Amneal Tramadol Hydrochloride Tablets
TraMADol Hydrochloride Tablets contain an impurity that failed specifications.
Summary by Recall Canary from the FDA notice
What happened
Amneal Pharmaceuticals, LLC, of Bridgewater, New Jersey, is recalling traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, because the N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of specification at the 24-month stability interval during long term stability. The recall began March 19, 2026, and was added to the FDA's Enforcement Report on March 30, 2026.
The tablets were distributed nationwide within the USA. The product is manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, and distributed by Amneal Pharmaceuticals LLC, Glasgow, KY 42141. The recall involves 29,542 bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles
- NDC
- 60219-2348-5
- Lot code
- AM230987
- AR232387
Recall details
- Company began the recall
- Sold in
Nationwide within the USA
- Company
- Amneal Pharmaceuticals, LLCBridgewater, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98623
- Recall number
- D-0408-2026
- Quantity recalled
- 29,542 bottles
All recalls from Amneal Pharmaceuticals, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
