Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Recall Number: D-0522-2026

Firm: Breckenridge Pharmaceutical, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260513

Initiation Date: 20260421

Termination Date:

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

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.