CLASS II Drug recall · Reported 14 Oct 2015 · FDA Enforcement Report
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg recalled
Merck Sharp & Dohme, Wilson Facility is recalling Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg, distributed in Kentucky, Mississippi, Ohio. The recall was initiated on 14 Aug 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0007-2016
- FDA event ID
- 72324
- Recalling firm
- Merck Sharp & Dohme, Wilson Facility, Wilson, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2015
- FDA classified
- 5 Oct 2015
- Reported
- 14 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 14 Aug 2015 | Recall initiated by company | |
| 5 Oct 2015 | Classified by FDA | +52 days |
| 14 Oct 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Product as listed by the FDA
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
Where it was distributed
KY, MS and OH.
Questions about this recall
Is Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg recalled?
Yes. Merck Sharp & Dohme, Wilson Facility recalled Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg on 14 Aug 2015. The recall is Class II and its status is Terminated. Recall number D-0007-2016.
Why was it recalled?
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Which lots are affected?
Lot number: L013425, Exp. 11/2016
Where was it sold?
KY, MS and OH.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.