GSMS Incorporated recall
FDA recall D-0587-2026 · initiated May 29, 2026
Golden State Medical Supply Inc. recalled GSMS Incorporated in May 2026 — an FDA Class II recall (D-0587-2026) because 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.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,961 bottles
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
Frequently asked
- Was GSMS Incorporated recalled?
- Golden State Medical Supply Inc. recalled GSMS Incorporated in May 2026 — an FDA Class II recall (D-0587-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was GSMS Incorporated recalled?
- Per the FDA enforcement record, the reason for recall D-0587-2026 was: 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.
- Is a recalled GSMS Incorporated dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of GSMS Incorporated are affected?
- Distributed: Within the U.S Market.. The recall covers these lots — Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0587-2026.