Asclemed USA Inc. recalls Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76
Recalled June 10, 2026 · FDA recall D-0555-2026 · Asclemed USA
Hazard
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. · FDA Class II
Units
50 bottles
Sold at
US Nationwide.
Description
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Product
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.
Manufacturer(s)
Asclemed USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →