Vytorin 10 mg/20 mg Recall: Foreign Tablet Risk
Merck Sharp & Dohme recalls Vytorin 10 mg/20 mg tablets due to the presence of foreign 10 mg/40 mg tablets in bottles.
Use caution until it’s fixed
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Contact the company
What happened, in plain English
Merck Sharp & Dohme is recalling specific lots of Vytorin (ezetimibe and simvastatin) 10 mg/20 mg tablets. The recall was issued because bottles intended to contain only the 10 mg/20 mg strength were found to contain foreign 10 mg/40 mg tablets. This error could lead to patients receiving an incorrect dosage of medication. Read more at govinfonow.com/recall/43851-merck-sharp-dohme-wilson-facility-recalls-vytorin-ezetimibe-and-simvastatin.
Source Summary by GovInfoNow · govinfonow.com/recall/43851-merck-sharp-dohme-wilson-facility-recalls-vytorin-ezetimibe-and-simvastatin · Updated October 12, 2026 · FDA enforcement record: FDA #D-0007-2016
Cite this page
“Vytorin 10 mg/20 mg Recall: Foreign Tablet Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43851-merck-sharp-dohme-wilson-facility-recalls-vytorin-ezetimibe-and-simvastatin. Based on FDA recall #D-0007-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2016%22&limit=1).
Why it’s dangerous
The hazard is a manufacturing error where tablets of a different strength (10 mg/40 mg) were mixed into bottles labeled as 10 mg/20 mg. Taking the wrong dosage of ezetimibe and simvastatin can result in improper treatment or unexpected side effects associated with the higher dose.
Who’s affected
Patients in Kentucky, Mississippi, and Ohio who purchased Vytorin 10 mg/20 mg tablets from the affected distribution pattern are at risk. Individuals taking this specific medication for cholesterol management may have received an incorrect strength.
How to tell if you have this one
Check your bottle for the label 'Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg' with NDC 66582-0312-82. Verify the lot number is L013425 and the expiration date is 11/2016. The product was distributed in KY, MS, and OH.
- Brand
Vytorin- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Vytorin bottle matches the lot number L013425 and expiration date 11/2016.
Contact Your Pharmacist
If you have the affected product, contact your pharmacist or healthcare provider immediately for guidance on replacement or disposal.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “KY, MS and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kentucky, Mississippi, Ohio.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0007-2016 (August 14, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0007-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.