Breckenridge Pharmaceutical, Inc.: Drug Recall

Recall #D-0308-2025 · 03/26/2025

Class II: Risk

Recall Details

Recall Number: D-0308-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Breckenridge Pharmaceutical, Inc.
Status: Ongoing
Date Initiated: 03/26/2025
Location: Berkeley Heights, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,863 bottles

Reason for Recall

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Product Description

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

Distribution Pattern

Nationwide in the US

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.