Stop using now Drug recall · FDA · Published April 23, 2024

Regeneron Recalls EYLEA Injection Due to Sterility and Breakage Risks

Regeneron recalls specific lots of EYLEA single-dose pre-filled syringes due to lack of sterility assurance and syringe breakage complaints.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0479-2024Drug Regeneron ›

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Lack of Assurance of Sterility: Complaints of syringe breakage

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Contact the company

Recalling firmRegeneron Pharmaceuticals Inc777 Old Saw Mill River Rd · Tarrytown, NY 10591-6717

✎ GovInfoNow plain-language explainer

Regeneron Pharmaceuticals is recalling specific lots of EYLEA (aflibercept) Injection, a prescription medication used for eye conditions. The recall addresses two serious issues: a lack of assurance that the product is sterile and reports of the syringes breaking during use. Because this involves a sterile injectable drug, there is a significant risk of infection or injury from broken glass. Read more at govinfonow.com/recall/32718-regeneron-recalls-eylea-injection-due-to-sterility-and-breakage-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/32718-regeneron-recalls-eylea-injection-due-to-sterility-and-breakage-risks · Updated October 9, 2026 · FDA enforcement record: FDA #D-0479-2024

Cite this page

“Regeneron Recalls EYLEA Injection Due to Sterility and Breakage Risks.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32718-regeneron-recalls-eylea-injection-due-to-sterility-and-breakage-risks. Based on FDA recall #D-0479-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0479-2024%22&limit=1).

Regeneron Pharmaceuticals Inc voluntarily recalled EYLEA injection syringes on April 23, 2024, due to a lack of sterility assurance and complaints of syringe breakage, the FDA said. The recall affects 251,504 units distributed nationwide.

How to tell if you have it

Brand: Regeneron
Product: EYLEA Injection Syringes
NDC: 61755-005-01
Lot #8231500321, Exp 10/31 24
Lot #8231500335, Exp 1/30/25
Lot #8231500333, Exp 1/30/25
Lot #8231500334, Exp 1/30/25
Lot #8231500339, Exp 1/30/25
Lot #8231500347, Exp 1/30/25

The hazard

The recall addresses a lack of assurance of sterility and complaints of syringe breakage. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Regeneron Pharmaceuticals Inc has two other recalls on record since May 15, 2024. On July 28, 2026, Regeneron recalled Libtayo injection for a lack of sterility assurance risk. On May 15, 2024, Regeneron recalled EYLEA injections due to sterility and breakage risks. Other recent recalls of similar products include Reliance Pemetrexed Injection Recall (June 24, 2026), EPINEPHR Sterility Risk in 1 mg/10mL Injection Recall (April 1, 2026), and Accord IMULDOSA Injection Recall (June 10, 2026).

How to tell if you have this one

Check your EYLEA single-dose pre-filled syringes for the following details: Manufacturer is Regeneron Pharmaceuticals, Inc. Look for NDC 61755-005-01. Affected lots are 8231500321 (Expiration 10/31/24), 8231500335, 8231500333, 8231500334, 8231500339, and 8231500347 (Expiration 1/30/25). The product is Rx only.

Brand
Regeneron
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the affected syringes
Do not use any EYLEA syringes matching the listed lot numbers and expiration dates due to sterility and breakage risks.
Contact your healthcare provider
Reach out to the doctor who prescribed or administered the medication to discuss next steps for replacement or alternative treatment.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Apr 23, 2024Firm started the recall
May 2, 2024FDA classified it Class II
May 8, 2024Published in FDA’s Enforcement Report
Sep 25, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the NDC number for this product?

The National Drug Code (NDC) for this recalled product is 61755-005-01.

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Link to this recall

<a href="https://govinfonow.com/recall/32718-regeneron-recalls-eylea-injection-due-to-sterility-and-breakage-risks">Regeneron Recalls EYLEA Injection Due to Sterility and Breakage Risks (GovInfoNow)</a>

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-0479-2024 (April 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0479-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.