Official recall notice
FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 10
- Recall date
- 2026-06-17
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recommended action
What to do
359,676 bottles
Product description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit