FDAFDA · Food and drugs·Recall number D-0587-2026
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
Published June 17, 2026 · Recall initiated: May 29, 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 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- NIACIN
- Manufacturer
- Golden State Medical Supply Inc.
- Distributor
- Within the U.S Market.
- Lot
- Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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