FDAHealthNovember 24, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain,
⚠️ CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 24, 2025
Nationwide within the United States
What's affected?
- 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
- DULOXETINE
- Lot code
- 240947C
Additional details
Lot #: 240947C, 240962C, Exp. Date 04/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3397 bottles.
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