FDAFDA · Food and drugs·Recall number D-0277-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Published March 26, 2025 · Recall initiated: March 5, 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 recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Rising Pharma Holding, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: DTB23111A, Exp 8/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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