FDAHealthMay 14, 2026
Asclemed USA Inc. — 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.
⚠️ CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 14, 2026
US Nationwide.
What's affected?
- 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.
- Brand
- DULOXETINE
- Lot code
- 050725G-30
Additional details
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 50 bottles.
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