Quick answers
- What is Eylea?
- Eylea is a brand name of Aflibercept, a prescription medicine. The FDA NDC Directory lists 1 Eylea product in 1 strength and form.
- Who makes Eylea?
- Regeneron Pharmaceuticals holds the FDA application for Eylea (BLA125387, approved November 18, 2011).
- Is there a generic or store brand of Eylea?
- Other products of Aflibercept are listed with the FDA, but none in exactly the same strength and form as a Eylea product.
- Has Eylea been recalled?
- FDA enforcement reports list 2 recalls of Eylea products; the newest started May 15, 2024. A recall usually concerns specific lots, not every product.
What Eylea is
Each Eylea product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Aflibercept · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| aflibercept 40 mg/mL injection, solution (intravitreal) | Eylea | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Aflibercept →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA125387 | Regeneron Pharmaceuticals | November 18, 2011 | 1 |
Companies that list Eylea
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Eylea products.
- Regeneron Pharmaceuticals, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 15, 2024 · Class II · Terminated · D-0531-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Roa — Regeneron Pharmaceuticals Inc
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April 23, 2024 · Class II · Terminated · D-0479-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755- — Regeneron Pharmaceuticals Inc
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.