Quick answers
- What is Ezetimibe and simvastatin used for?
- The FDA-approved label (Vytorin, Organon LLC, January 21, 2026) says: “VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ezetimibe and simvastatin have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ezetimibe and simvastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ezetimibe and simvastatin been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started May 19, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Ezetimibe and simvastatin?
- 8 companies list prescription products of Ezetimibe and simvastatin in the FDA NDC Directory, including Aurobindo Pharma Limited, Dr.Reddys Laboratories Inc and Golden State Medical Supply, Inc..
What Ezetimibe and simvastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). …
— FDA label: Vytorin, Organon LLC, effective January 21, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 28 in the FDA NDC Directory |
| Brand names | Vytorin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ezetimibe 10 mg · simvastatin 10 mg tablet | Generic | $0.2648 per tablet |
| ezetimibe 10 mg · simvastatin 20 mg tablet | Generic | $0.1848 per tablet |
| ezetimibe 10 mg · simvastatin 20 mg tablet | Brand: Vytorin | $13.62 per tablet |
| ezetimibe 10 mg · simvastatin 40 mg tablet | Generic | $0.1904 per tablet |
| ezetimibe 10 mg · simvastatin 40 mg tablet | Brand: Vytorin | $13.80 per tablet |
| ezetimibe 10 mg · simvastatin 80 mg tablet | Generic | $0.2726 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aurobindo Pharma Limited4 products
- Dr.Reddys Laboratories Inc4 products
- Golden State Medical Supply, Inc.4 products
- Organon LLC4 products
- Ascend Laboratories, LLC4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- NorthStar Rx LLC2 products
- A-S Medication Solutions2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021687 VYTORIN | Organon | July 23, 2004 | 43, latest March 28, 2024 2024: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (4)
- ANDA200909DR Reddys Labs SA · April 26, 2017
- ANDA209222Alkem Labs Ltd · December 22, 2017
- ANDA208699Glenmark Pharms Ltd · June 27, 2019
- ANDA200082Aurobindo Pharma USA · December 17, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 19, 2025 · Class III · Ongoing · D-0462-2025
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceutica — Glenmark Pharmaceuticals Inc., USA
-
October 14, 2021 · Class II · Terminated · D-0227-2022
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC — Golden State Medical Supply Inc.
-
October 14, 2021 · Class II · Terminated · D-0228-2022
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193- — Golden State Medical Supply Inc.
-
October 5, 2021 · Class II · Terminated · D-0081-2022
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, US — Dr. Reddy's Laboratories, Inc.
-
October 5, 2021 · Class II · Terminated · D-0082-2022
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Di — Dr. Reddy's Laboratories, Inc.
-
October 5, 2021 · Class II · Terminated · D-0084-2022
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Di — Dr. Reddy's Laboratories, Inc.
-
October 5, 2021 · Class II · Terminated · D-0085-2022
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeto — Dr. Reddy's Laboratories, Inc.
-
October 5, 2021 · Class II · Terminated · D-0083-2022
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories — Dr. Reddy's Laboratories, Inc.
-
March 15, 2021 · Class II · Terminated · D-0484-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vytorin, Organon LLC, effective January 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →