FDAFDA · Food and drugs·Recall number D-0584-2026
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Published June 10, 2026 · Recall initiated: May 27, 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
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NIACIN
- Manufacturer
- Lannett Company Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0362175320469
- Lot
- Lot #: 25282724A, Exp. Date 2027/01
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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