Class IIReported 2025-12-10

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

Reason for Recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Recall Number

D-0215-2026

Classification

Class II

Status

Ongoing