Reported Apr 8, 2026 · Ongoing
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt.…
Amneal Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India
- Distributed byAmneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5
- Lot codes and dates
Lot #: AM230987Exp. Date 05/2026AR232387Exp. Date 12/2026
- Amount recalled
- 29,542 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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