EZETIMIBE AND SIMVASTATIN
Recalling Firm / Manufacturer: Glenmark Pharmaceuticals Inc., USA
(Mahwah, NJ, United States)
FDA Recall Number: D-0462-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
EZETIMIBE AND SIMVASTATIN
Generic Name
EZETIMIBE AND SIMVASTATIN
Active Substance(s)
Ezetimibe, Simvastatin
Administration Route
Oral
National Drug Code (NDC)
68462-321
Total Quantity Recalled
6,759 Con - 90 bottle pack
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
June 18, 2025
Firm Initiation Date
May 19, 2025
FDA Classification Date
Jun 10, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 17240195, Exp 01/31/2026.
Distribution Information
Geographic scope of affected shipments
Nationwide USA and PR
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0462-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508616UTCC