Official recall notice
FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc
- Recall date
- 2026-05-13
- Brand
- Ajanta Pharma Ltd.
- Category
- Drug
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
77,376 packs.
Product description
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.