Niacin Tablet, Extended Release
FDA Recall NDC 51407-267
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Niacin (NDC 51407-267). A significant event, classified as Class II, was initiated on Oct 20, 2025 by Golden State Medical Supply, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Oct 20, 2025
Nov 26, 2025
24,869 bottles
Recall Profile & Regulatory Data
Event ID
97859
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
Batch or Lot Expiration Information
Lot# Lot, expiry: 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
Affected Packages Involved in this Recall
51407-267-90Product
51407-268-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
