Drug recall D-0555-2026
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 for recall
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Lots and codes
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Recall details
- Recalling firm
- Asclemed USA Inc., Torrance, CA
- Quantity
- 50 bottles
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 14, 2026
Related products
- Duloxetine – drug information
- NDC 76420-636 Duloxetine · Duloxetine Hydrochloride 40 mg/1 · Asclemed USA, Inc.
- NDC 76420-623 Duloxetine · Duloxetine Hydrochloride 60 mg/1 · Asclemed USA, Inc.
- NDC 76420-633 Duloxetine · Duloxetine Hydrochloride 20 mg/1 · Asclemed USA, Inc.
- NDC 76420-634 Duloxetine · Duloxetine Hydrochloride 30 mg/1 · Asclemed USA, Inc.