FDAFDA · Food and drugs·Recall number D-0462-2025
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
Published June 18, 2025 · Recall initiated: May 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide USA and PR
- UPC
- 0368462321300
- Lot
- Lot #: 17240195, Exp 01/31/2026.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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