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
Asclemed USA is recalling specific lots of Duloxetine Delayed-Release Capsules due to the presence of the nitrosamine impurity N-nitroso-duloxetine at levels exceeding the FDA acceptable intake limit. This recall is due to current good manufacturing practice (CGMP) deviations.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0555-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Asclemed USA Inc.
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