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 recalls 9 since 2021
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 1 latest 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
Ongoing ezetimibe recalls 1 active
All ezetimibe recalls, newest first 9 total
Reported Class Recall Company Reason Where 18 Jun 2025 Drug CLASS III Ezetimibe and Simvastatin Tablets, 10mg/40mg recalled Ezetimibe And Simvastatin Glenmark Pharmaceuticals Inc., U Potency & Assay Nationwide 17 Nov 2021 Drug CLASS II Ezetimibe and Simvastatin Tablets, 10 mg/80mg recalled Ezetimibe And Simvastatin Golden State Medical Supply Potency & Assay AZ, MO 17 Nov 2021 Drug CLASS II Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalled Ezetimibe And Simvastatin Golden State Medical Supply Potency & Assay AZ, MO 10 Nov 2021 Drug CLASS II Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) recalled Ezetimibe And Simvastatin Dr. Reddy's Laboratories Potency & Assay Nationwide 10 Nov 2021 Drug CLASS II Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg recalled Ezetimibe And Simvastatin Dr. Reddy's Laboratories Potency & Assay Nationwide 10 Nov 2021 Drug CLASS II Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) recalled Ezetimibe And Simvastatin Dr. Reddy's Laboratories Potency & Assay Nationwide 10 Nov 2021 Drug CLASS II Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) recalled Ezetimibe And Simvastatin Dr. Reddy's Laboratories Potency & Assay Nationwide 10 Nov 2021 Drug CLASS II Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) recalled Ezetimibe And Simvastatin Dr. Reddy's Laboratories Potency & Assay Nationwide 2 Jun 2021 Drug CLASS II Ezetimibe And Simvastatin Tablets 10-10mg recalled by Cardinal Health Ezetimibe And Simvastatin Cardinal Health Manufacturing (CGMP) Deviations FL, 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.