United StatesDuloxetine DR Capsules, 30 mg, 30-count bottles relabeled by Enovachem Pharmaceuticals (NDC 76420-634-30), marketed by Ajanta Pharma USA Inc., lots 050725G-30 and 050725F-30, exp. 06/30/2026, sold nationwide in the U.S., are affected. They were recalled by Asclemed USA Inc. due to CGMP deviations and the presence of the nitrosamine impurity N-nitroso-duloxetine above the FDA’s acceptable intake limit.
What's being recalled
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Recalling firm: Asclemed USA Inc., Torrance, CA, United States.
How to identify it
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
The hazard
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)