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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Niacin Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: November 19, 2025
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Summary

Golden State Medical Supply Inc. is recalling 24,869 bottles of Niacin (vitamin B3) 1,000 mg Extended-Release Tablets because the medication failed dissolution specifications. This defect means the drug may not dissolve correctly in the body, which can prevent it from working as intended. The recalled prescription medication was distributed nationwide in the United States in 90-count bottles.

Risk

The tablets may not break down and release the medication at the required rate, potentially leading to ineffective treatment of the patient's condition. No injuries or adverse events have been reported to date.

What You Should Do

  1. Locate your Niacin Extended-Release Tablets (1,000 mg, 90-count bottle) and check the label for NDC 51407-268-90.
  2. Check the lot number and expiration date printed on your bottle against the list of 24 affected codes, which include lots such as GS044385 (exp 10/2025), GS053612 (exp 04/2026), and GS058077 (exp 05/2026). See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: NIACIN Extended-Release Tablets, USP (1,000 mg, 90 tablets per bottle)
Variants: 1,000 mg, Extended-Release, Tablet
Lot Numbers:
GS044385 (exp 10/2025)
GS044979 (exp 10/2025)
GS045797 (exp 12/2025)
GS046415 (exp 12/2025)
GS047197 (exp 02/2026)
GS047786 (exp 02/2026)
GS048477 (exp 02/2026)
GS049480 (exp 03/2026)
GS048873 (exp 03/2026)
GS049733 (exp 03/2026)
GS050224 (exp 03/2026)
GS050721 (exp 03/2026)
GS050722 (exp 03/2026)
GS051145 (exp 03/2026)
GS051726 (exp 03/2026)
GS052484 (exp 03/2026)
GS053612 (exp 04/2026)
GS054987 (exp 05/2026)
GS054409 (exp 05/2026)
GS055697 (exp 05/2026)
GS056192 (exp 05/2026)
GS056886 (exp 05/2026)
GS058077 (exp 05/2026)
GS057330 (exp 05/2026)
NDC:
51407-268-90

Manufactured by Kremers Urban Pharmaceuticals, Inc. (subsidiary of Lannett Company, Inc.) and packaged by GSMS, Incorporated.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97859
Status: Active
Manufacturer: Golden State Medical Supply Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 24,869 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.