D-0215-2026 Class II Ongoing
FDA drug recall D-0215-2026 was initiated by Breckenridge Pharmaceutical, Inc. on November 24, 2025 and is designated Class II. Reason for recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit The recall status is ongoing. Affected quantity: 3397 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 10, 2025
- Initiation Date
- November 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3397 bottles
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 240947C, 240962C, Exp. Date 04/2027