Recall RadartraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmace…
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).
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Amneal Pharmaceuticals, LLC — Bridgewater, NJ
- Severity
- Class II — moderate
- Reported
- April 8, 2026
- Quantity
- 29,542 bottles
- Recall number
- D-0408-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within the USA
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