FDAHealthJune 30, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Br
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2025
U.S. Nationwide
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
- Brand
- DULOXETINE
- Lot code
- 230199
Additional details
Lot # 230199, Exp. Date 01/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12,242 30-count bottles.
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