Ezetimibe And Simvastatin Tablet
FDA Recall NDC 68462-321
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 Ezetimibe And Simvastatin (NDC 68462-321). A significant event, classified as Class III, was initiated on May 19, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study."
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 III Ongoing
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
May 19, 2025
Jun 18, 2025
6,759 Con - 90 bottle pack
Recall Profile & Regulatory Data
Event ID
96884
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and PR
Product Description
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Batch or Lot Expiration Information
Lot# : 17240195, Exp 01/31/2026.
Affected Packages Involved in this Recall
68462-321-90Product
68462-321-10Product
68462-321-30Product
68462-322-30Product
68462-322-90Product
68462-322-10Product
68462-323-30Product
68462-323-90Product
68462-323-05Product
68462-324-30Product
68462-324-90Product
68462-324-05Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
7 CARTON
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
Batch or Lot Expiration Information
Lot# 17201603
Affected Packages Involved in this Recall
68462-321-90Product
68462-321-10Product
68462-321-30Product
68462-322-30Product
68462-322-90Product
68462-322-10Product
68462-323-30Product
68462-323-90Product
68462-323-05Product
68462-324-30Product
68462-324-90Product
68462-324-05Product
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.
