Niacin Extended-Release Tablets Recalled for Failing Dissolution Specifications

Key Clinical Summary

• Golden State Medical Supply Inc voluntarily recalled Niacin extended-release (ER) tablets, USP, 1000 mg (Rx only) after failing dissolution specifications, potentially impacting drug release and effectiveness.
• The Class II recall affects 24 869 bottles from multiple lots (expiration 10/2025-05/2026), distributed nationwide.
• Niacin ER is indicated for dyslipidemia management, reducing LDL-C, triglycerides, and total cholesterol while raising HDL-C. Pharmacists should verify stock and counsel patients as needed.

Golden State Medical Supply Inc, in coordination with Kremers Urban Pharmaceuticals, Inc, a subsidiary of Lannett Company, Inc, has initiated a voluntary nationwide Class II recall of Niacin ER tablets, USP, 1000 mg (Rx only). The affected product, distributed in 90-count bottles (NDC 51407-268-90), was manufactured in Seymour, Indiana, and packaged by GSMS in Camarillo, California. The recall encompasses 24 869 bottles across numerous lot numbers with expiration dates ranging from October 2025 to May 2026.

The recall was initiated after the product failed dissolution specifications during stability testing, meaning the tablets may not properly release the active ingredient over time as intended. Such deviations from dissolution standards could affect the drug’s bioavailability and clinical effectiveness, particularly for patients using niacin extended-release formulations to manage lipid disorders. The firm notified consignees by letter on October 20, 2025, and the recall remains ongoing under US Food and Drug Administration (FDA) Event ID 97859. The FDA officially classified the recall as Class II on November 19, 2025, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Niacin (vitamin B3) extended-release tablets are indicated for the treatment of dyslipidemia, specifically to lower elevated total cholesterol, LDL-C, triglycerides, and apolipoprotein B, while increasing HDL-C. Pharmacists should check inventory for the affected lots and advise patients accordingly, as proper dissolution is essential for maintaining therapeutic efficacy and minimizing side effects such as flushing or hepatotoxicity.