Asclemed USA Inc.: Duloxetine Dr Capsules, 30 Mg
Duloxetine DR Capsules, 30 mg (a depression and anxiety medication) made by Asclemed USA Inc. and relabeled by Enovachem Pharmaceuticals are being recalled nationwide because they contain higher-than-acceptable levels of a nitrosamine impurity. The affected product is the 30-count bottle with NDC 76420-634-30, distributed throughout the United States.
- Recalling firm
- Asclemed USA Inc.
- 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.
- Reason
- CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/ebecea7e-25e3-4ca2-beaf-d806b5c113c0