Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: ...
FDA Recall #D-0215-2026 — Class II — November 24, 2025
Product Description
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.
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recalling Firm
Breckenridge Pharmaceutical, Inc. — Berkeley Heights, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3397 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 240947C, 240962C, Exp. Date 04/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated