Quick answers
- What is Icosapent ethyl used for?
- The FDA-approved label (Vascepa, Bryant Ranch Prepack, April 7, 2026) says: “VASCEPA ® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Icosapent ethyl have a boxed warning?
- No. None of the 28 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Icosapent ethyl?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 1, 2026). Ask your pharmacist about alternatives.
- Has Icosapent ethyl been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 9, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Icosapent ethyl?
- 19 companies list prescription products of Icosapent ethyl in the FDA NDC Directory, including Bryant Ranch Prepack, Amarin Pharma Inc. and Epic Pharma, LLC.
What Icosapent ethyl is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VASCEPA ® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. …
— FDA label: Vascepa, Bryant Ranch Prepack, effective April 7, 2026. Read the full label on DailyMed →
The FDA has 28 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 28 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, liquid filled |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Vascepa |
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 |
|---|---|---|
| icosapent ethyl 0.5 g capsule | Generic | $0.3483 per capsule |
| icosapent ethyl 1 g capsule | Generic | $0.4481 per capsule |
| icosapent ethyl 1 g capsule, liquid filled | Generic | $0.4481 per capsule |
| icosapent ethyl 1000 mg capsule | Generic | $0.4481 per capsule |
| icosapent ethyl 500 mg capsule | Generic | $0.3483 per capsule |
| icosapent ethyl 500 mg capsule, liquid filled | Generic | $0.3483 per capsule |
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.
- Bryant Ranch Prepack8 products
- Amarin Pharma Inc.4 products
- Epic Pharma, LLC3 products
- NorthStar Rx LLC2 products
- Teva Pharmaceuticals, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- XLCare Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Softgel Healthcare Private Limited2 products
- Camber Pharmaceuticals, Inc.2 products
- Dr. Reddy's Laboratories Inc.2 products
- Golden State Medical Supply, Inc.1 product
- Torrent Pharmaceuticals Limited1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Vitruvias Therapeutics, Inc.1 product
- Aurobindo Pharma Limited1 product
- Apotex Corp.1 product
- American Health Packaging1 product
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 |
|---|---|---|---|
| NDA202057 VASCEPA | Amarin Pharms | July 26, 2012 | 18, latest March 16, 2026 2026: Manufacturing (CMC) · 2019: Efficacy · 2017: Manufacturing (CMC) |
Generic approvals (12)
- ANDA209457Hikma · May 21, 2020
- ANDA209499DR Reddys · August 7, 2020
- ANDA209525Teva Pharms USA · September 11, 2020
- ANDA209437Apotex · June 30, 2021
- ANDA217656Zydus Lifesciences · April 20, 2023
- ANDA217844Onesource · September 22, 2023
- ANDA216811Ascent Pharms Inc · December 7, 2023
- ANDA217919Humanwell Puracap · December 22, 2023
- ANDA218899Qilu · November 20, 2024
- ANDA218994Torrent · December 20, 2024
- ANDA219156Xiamen LP Pharm Co · August 6, 2025
- ANDA218949Aurobindo Pharma Ltd · June 24, 2026
Shortage status
To be discontinued · updated April 1, 2026 · first posted April 1, 2026
| Product | Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12) |
|---|---|
| Company | Apotex Corp. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
March 9, 2026 · Class II · Ongoing · D-0400-2026
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Zydus Pharmaceuticals (USA) Inc
-
May 30, 2025 · Class II · Completed · D-0497-2025
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7. — Zydus Pharmaceuticals (USA) 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
| RxCUI (RxNorm) | 1304979, 1304985, 1811180, 1811182 |
|---|---|
| SPL set ID of the quoted label | d245ddab-d81b-44bd-90d7-0e4d446d9bf5 |
| FDA labels (SPL) | 28 |
| FDA applications | NDA202057, 12 ANDA |
| Active ingredients (FDA) | ICOSAPENT ETHYL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vascepa, Bryant Ranch Prepack, effective April 7, 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 →