Official recall notice
FDA DrugClass IINotable
FDA Recall: traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pha
- Recall date
- 2026-04-08
- Category
- Drug
- FDA class
- Class II
Why it was recalled
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).
Recommended action
What to do
29,542 bottles
Product description
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).