Breckenridge Pharmaceutical, Inc.: Drug Recall

Recall #D-0580-2025 · 07/25/2025

Class II: Risk

Recall Details

Recall Number: D-0580-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc.
Status: Ongoing
Date Initiated: 07/25/2025
Location: Berkeley Heights, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,856 bottles

Reason for Recall

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

Product Description

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10

Distribution Pattern

NJ, AZ, IN

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 10/09/2025

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II: Risk 08/08/2025

CGMP deviations: N-nitroso-duloxetine impurity above the proposed 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.