FDAFDA · Food and drugs·Recall number D-0216-2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Published December 10, 2025 · Recall initiated: November 24, 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 the FDA recommended limit
What to do
Voluntary: Firm initiated
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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