FDAFDA · Food and drugs·Recall number D-0555-2026
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.
Published June 10, 2026 · Recall initiated: May 14, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Asclemed USA Inc.
- Distributor
- US Nationwide.
- Lot
- Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.