Recalling firm
Breckenridge Pharmaceutical, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-10
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
3397 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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.
Code / lot info
Lot #: 240947C, 240962C, Exp. Date 04/2027
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.