Class IIReported 2025-08-13

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Recall Number

D-0552-2025

Classification

Class II

Status

Ongoing