FDAHealthApril 21, 2026
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Brecke
⚠️ 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
- April 21, 2026
Nationwide in the USA
What's affected?
- Product
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
- Brand
- DULOXETINE
- Lot code
- 241069C
Additional details
Lot: 241069C, Exp 05/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 165,761 90-count bottles.
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