FDAHealthJune 4, 2026
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, D
⚠️ 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 4, 2026
Nationwide within the United States
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
- Brand
- DULOXETINE
- Lot code
- 241180C
Additional details
Lot: 241180C, Exp. Date April 2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,729 bottles..
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