Breckenridge Pharmaceutical, Inc: Drug Recall

Recall #D-0388-2025 · 04/14/2025

Class II: Risk

Recall Details

Recall Number: D-0388-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc
Status: Ongoing
Date Initiated: 04/14/2025
Location: Berlin, CT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 343,344 bottles

Reason for Recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Product Description

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

Distribution Pattern

US 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 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 07/25/2025

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