Class IIOngoing

GSMS Incorporated recall

FDA recall D-0587-2026 · initiated May 29, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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.

Details

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.
Recalling company: Golden State Medical Supply Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Within the U.S Market.
Initiated: May 29, 2026
FDA report date: Jun 17, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0587-2026 ↗

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