D-0587-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2026
- Initiation Date
- May 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,961 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Within the U.S Market.
Code Information
Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.