HIGHFDA DRUG
Duloxetine Capsules Recalled Over High N-Nitroso Impurity Risk
Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.
DULOXETINE
CGMP Deviations;