FDAHealthMay 19, 2025

Glenmark Pharmaceuticals Inc., USA — 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

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 19, 2025

Nationwide USA and PR

What's affected?

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
Brand: EZETIMIBE AND SIMVASTATIN
UPC: 0368462321300
Lot code: 17240195

Additional details

Lot #: 17240195, Exp 01/31/2026.

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 6,759 Con - 90 bottle pack.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.