Recalls / Class II
Class IID-0215-2026
Product
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.
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 82009-029, 82009-030, 82009-032, 82009-031
- FDA application
- ANDA203088
- Affected lot / code info
- Lot #: 240947C, 240962C, Exp. Date 04/2027
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Manufacturer
- Quallent Pharmaceuticals Health, LLC
- Type
- Voluntary: Firm initiated
- Address
- 200 Connell Dr Ste 4200, Berkeley Heights, New Jersey 07922-2805
Distribution
- Quantity
- 3397 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-11-24
- FDA classified
- 2025-12-03
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0215-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.