FDA recall D-0587-2026

Golden State Medical Supply Inc. · Class II · drug

Product

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

Within the U.S Market.

Key facts

Status
Ongoing
Initiation date
2026-05-29
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0587-2026