Official recall notice
FDA DrugClass IINotable
FDA Recall: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutica
- Recall date
- 2026-05-13
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recommended action
What to do
165,761 90-count bottles
Product description
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit