Duloxetine DR Capsules 30 mg
Asclemed USA is recalling Duloxetine DR Capsules 30 mg due to the presence of a nitrosamine impurity above acceptable intake limits.
Contact your healthcare provider or pharmacist to discuss alternative treatment options. Do not stop taking your medication without consulting a medical professional.
Why it was recalled
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
How to identify it
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.
Official source
Editorial summary by Recall Canary · last updated 2026-06-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification