Breckenridge Pharmaceutical, Inc.: Drug Recall

Recall #D-0100-2026 · 10/09/2025

Class II: Risk

Recall Details

Recall Number: D-0100-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc.
Status: Ongoing
Date Initiated: 10/09/2025
Location: Berkeley Heights, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 172,263 bottles

Reason for Recall

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Product Description

Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.

Distribution Pattern

U.S. Nationwide

Other Recalls by Breckenridge Pharmaceutical, Inc.

Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 11/24/2025

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II: Risk 08/08/2025

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Class II: Risk 07/25/2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Class II: Risk 07/15/2025

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

View all recalls by Breckenridge Pharmaceutical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.