FDA Drug · D-0215-2026

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

Class II · Ongoing

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Affected lots / codes — check yours against thisLot #: 240947C, 240962C, Exp. Date 04/2027

Recalling firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 3397 bottles
Distribution: Nationwide within the United States
Recall initiated: November 24, 2025
Classified: December 3, 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-0215-2026%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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