FDAFDA · Food and drugs·Recall number D-0552-2025
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.
Published August 13, 2025 · Recall initiated: July 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Distributor
- U.S Nationwide
- Lot
- Lot: 230836C, Exp.: 02/28/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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