Asclemed USA Inc.: Duloxetine Dr Capsules, 30 Mg
Recall Summary Asclemed USA Inc. is recalling Duloxetine DR Capsules 30 mg bottles (a medication used to treat depression and anxiety) because they contain higher-than-acceptable levels of a nitrosamine impurity created during manufacturing. The recalled bottles were distributed nationwide under NDC 76420-634-30 and marketed by Ajanta Pharma USA Inc.
- 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/c4692939-0999-4cc7-9041-3a41402433ad