FDAFDA · Food and drugs·Recall number D-0408-2026
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.
Published April 8, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated
Recall details
- Brand
- TRAMADOL HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Distributor
- Nationwide within the USA
- Lot
- Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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