FDAHealthJuly 15, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 15, 2025
U.S Nationwide
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
- Brand
- DULOXETINE
- Lot code
- 230836C
Additional details
Lot: 230836C, Exp.: 02/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,829 60-count bottles.
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