Niacin Tablet, Extended Release
FDA Recall NDC 62175-320
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Niacin (NDC 62175-320). A significant event, classified as Class II, was initiated on May 27, 2026 by Lannett Company, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint."
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: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
May 27, 2026
Jun 10, 2026
3984 bottles
Recall Profile & Regulatory Data
Event ID
99107
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Batch or Lot Expiration Information
Lot# : 25282724A, Exp. Date 2027/01
Affected Packages Involved in this Recall
62175-320-46Product
62175-320-43Product
62175-322-46Product
62175-322-43Product
Class II Ongoing
Failed Dissolution Specifications
Oct 10, 2025
Oct 29, 2025
46,848 90-count bottles
Recall Profile & Regulatory Data
Event ID
97778
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lannett Company Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Batch or Lot Expiration Information
Lot# Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
Affected Packages Involved in this Recall
62175-320-46Product
62175-320-43Product
62175-322-46Product
62175-322-43Product
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.
