Official recall notice

FDA DrugClass IINotable

FDA Recall: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torran

Recall date
2026-06-10
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Recommended action

What to do

50 bottles

Product description

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

Verify with the official notice →
Share:

Related Recalls

2026-07-29 · FDA_DRUG
FDA Recall: Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx
Asclemed USA Inc.
2026-07-08 · FDA_DRUG
FDA Recall: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Onl
Asclemed USA Inc.
2026-07-08 · FDA_DRUG
FDA Recall: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovach
Asclemed USA Inc.