Official recall notice
FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsule
- 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
312,894 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.