FDAFDA · Food and drugs·Recall number D-0582-2026
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
Published June 17, 2026 · Recall initiated: June 4, 2026
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 FDA recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot: 241180C, Exp. Date April 2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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