FDA Drug · D-0582-2026

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot: 241180C, Exp. Date April 2027.

Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 14,729 bottles.
Distribution: Nationwide within the United States
Recall initiated: June 4, 2026
Classified: June 8, 2026
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-0582-2026%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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