Recalls / Class II
Class IID-0408-2026
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.
- Brand name
- Tramadol Hydrochloride
- Generic name
- Tramadol Hydrochloride
- Active ingredient
- Tramadol Hydrochloride
- Route
- Oral
- NDC
- 60219-2348
- FDA application
- ANDA076003
- Affected lot / code info
- Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
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).
Recalling firm
- Firm
- Amneal Pharmaceuticals, LLC
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Type
- Voluntary: Firm initiated
- Address
- 400 Crossing Blvd Fl 3, Bridgewater, New Jersey 08807-2863
Distribution
- Quantity
- 29,542 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2026-03-19
- FDA classified
- 2026-03-30
- Posted by FDA
- 2026-04-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0408-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.