FDAHealthJuly 25, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Sp
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Is this relevant to me?
- Geography
- NJ, AZ, IN
- Source agency
- FDA
- Category
- Health
- Published
- July 25, 2025
NJ, AZ, IN
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
- Brand
- DULOXETINE
- Lot code
- 240539C
Additional details
Lot 240539C, Exp 1/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,856 bottles.
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