CLASS II ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalled
Golden State Medical Supply is recalling Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG. The recall was initiated on 29 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0587-2026
- FDA event ID
- 99127
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Brand
- Niacin
- Manufacturer
- Golden State Medical Supply, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2026
- FDA classified
- 11 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 29 May 2026 | Recall initiated by company | |
| 11 Jun 2026 | Classified by FDA | +13 days |
| 17 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Within the U.S Market.
Questions about this recall
Why was it 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.
Which lots are affected?
Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
Where was it sold?
Within the U.S Market.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Niacin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP, 1,000 mg recalledNiacin | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP 1000mg recalledNiacin | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP 500mg recalledNiacin | SUN Pharmaceutical Industries | Sterility | Nationwide |