Ezetimibe recalls

The FDA has published 9 recalls involving Ezetimibe since 2021. The latest was reported on 18 Jun 2025. Most were for potency & assay. Dr. Reddy's Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls9since 2021
Last 12 months0reported
Class I00% of total
Ongoing1latest 18 Jun 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 8 89%Class III 1 11%

Why ezetimibe is recalled

By year

Ongoing ezetimibe recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIEzetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And SimvastatinGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide

All ezetimibe recalls, newest first

9 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIEzetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And SimvastatinGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IIEzetimibe and Simvastatin Tablets, 10 mg/80mg recalledEzetimibe And SimvastatinGolden State Medical SupplyPotency & AssayAZ, MO
DrugCLASS IIEzetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalledEzetimibe And SimvastatinGolden State Medical SupplyPotency & AssayAZ, MO
DrugCLASS IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) recalledEzetimibe And SimvastatinDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg recalledEzetimibe And SimvastatinDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) recalledEzetimibe And SimvastatinDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) recalledEzetimibe And SimvastatinDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) recalledEzetimibe And SimvastatinDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIEzetimibe And Simvastatin Tablets 10-10mg recalled by Cardinal HealthEzetimibe And SimvastatinCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC

Should you stop taking Ezetimibe?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.