Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

Recall Number: D-0511-2025

Firm: Breckenridge Pharmaceutical, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20250716

Initiation Date: 20250630

Termination Date:

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.