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Drug FDA Class III Ongoing Failed specifications

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

Glenmark Pharmaceuticals Inc., USA Published Jun 18, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Anhydro Simvastatin · primary

Affected products (1)

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

EZETIMIBE AND SIMVASTATIN · 6,759 Con - 90 bottle pack

NDC: 68462-321, 68462-322, 68462-323, 68462-324, 68462-321-90, 68462-321-10, 68462-321-30, 68462-322-30, 68462-322-90, 68462-322-10, 68462-323-30, 68462-323-90, 68462-323-05, 68462-324-30, 68462-324-90, 68462-324-05
Code info: Lot #: 17240195, Exp 01/31/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 19, 2025
  2. Published
    Jun 18, 2025
Recall number
D-0462-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.