Official recall notice
FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Tow
- 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
14,729 bottles.
Product description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit