FDA Drugs recall ·
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only… recall
- Recall number
- D-0408-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29,542 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Distribution
Nationwide within the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0408-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.