Ezetimibe recalls

The FDA has published 10 recalls involving Ezetimibe since 2019. 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 recalls10since 2019
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 9 90%Class III 1 10%

By year

Ongoing ezetimibe recalls

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

All ezetimibe recalls, newest first

10 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIEzetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And SimvastatinGlenmark Pharmaceuticals Inc., USAPotency & 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
DrugCLASS IIEzetimibe and Simvastatin Tablets 10mg/80 mg recalledDr. Reddy's LaboratoriesOtherNationwide

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.