FDA Drug · D-0388-2025

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026

Recalling firm: Breckenridge Pharmaceutical, Inc, Berlin, CT
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 343,344 bottles
Distribution: US Nationwide.
Recall initiated: April 14, 2025
Classified: April 22, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0388-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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