# 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. — FDA Safety Label Change

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

**Manufacturer:** Asclemed USA Inc.
**Date of action:** 20260610
**Canonical URL:** https://drugsmonitor.com/recall/593f59d8-7a96-4a91-a958-b4d6f11cf72b
**Last updated:** 2026-06-11

## Summary

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. (Asclemed USA Inc.) — Safety Label Change on 20260610.

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

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*