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Class III · Lower riskActive recall

Ezetimibe And Simvastatin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 17240195, Exp 01/31/2026.
Where it was soldNationwide USA and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 foreign manufacturer
Brand nameEZETIMIBE AND SIMVASTATIN
Generic nameEZETIMIBE AND SIMVASTATIN
Active ingredient(s)EZETIMIBE, SIMVASTATIN
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
NDC68462-323-90
Show the full FDA record
Full product labelEzetimibe 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 firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide USA and PR
Quantity6,759 Con - 90 bottle pack
Recall initiated2025-05-19
Report date2025-06-18
Recall completed—
Recall numberD-0462-2025
ClassificationClass III
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.