Glenmark Pharmaceuticals recalls 10mg/40mg Ezetimibe and Simvastatin tablets due to impurity issues detected during long-term stability testing. Affected lots may pose risks if stored beyond expiration.
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.
Glenmark Pharmaceuticals is recalling certain Ezetimibe and Simvastatin tablets because tests found impurities that could become problematic after long-term storage. This recall affects prescription-only bottles with specific lot numbers and expiration dates.
The tablets showed impurities (specifically Anhydro Simvastatin) that failed quality tests during long-term stability studies. This indicates potential degradation over time, though the exact risk level is not specified in the recall notice.
Prescription holders of the 10mg/40mg Ezetimibe and Simvastatin tablets with lot number 17240195 and expiration date 01/31/2026 are affected. Patients using these medications for cholesterol management are most at risk.
Check for the product name 'Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle' with the lot number 17240195 and expiration date 01/31/2026. The product is prescription-only and manufactured by Glenmark Pharmaceuticals Ltd. in India.
Verify the lot number and expiration date on the bottle to confirm if it matches the recalled batch (lot 17240195, exp 01/31/2026).
The recall is due to impurities (Anhydro Simvastatin) detected in the tablets during long-term stability testing, which failed quality specifications.
The recall notice does not specify any remedy or action for consumers.
Check the lot number and expiration date on the bottle. If it matches the recalled batch (lot 17240195, exp 01/31/2026), contact your healthcare provider for guidance.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0462-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0462-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
