Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Recall Number: D-0271-2025

Firm: Breckenridge Pharmaceutical, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20250319

Initiation Date: 20250228

Termination Date:

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

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05