FDAFDA · Food and drugs·Recall number D-0516-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Published May 13, 2026 · Recall initiated: April 29, 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 N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Ajanta Pharma Ltd.
- Distributor
- Nationwide within U.S
- UPC
- 0327241164309
- Lot
- Lot#: PA10734, Exp. Jun 2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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