Class IIIOngoing

Ezetimibe and Simvastatin Tablets recall

FDA recall D-0462-2025 · initiated May 19, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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.

Details

Product: 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
Recalling company: Glenmark Pharms
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide USA and PR
Initiated: May 19, 2025
FDA report date: Jun 18, 2025

This recall is linked to a product we cover: Ezetimibe and Simvastatin →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0462-2025 ↗

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