Stop using now Drug recall · FDA · Published May 15, 2024

Regeneron Recalls EYLEA Injections Due to Sterility and Breakage Risks

Regeneron recalls 405,725 EYLEA prefilled syringes due to lack of sterility assurance and syringe breakage complaints. Check lot numbers immediately.

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

🇺🇸 FDA recall #D-0531-2024Drug Regeneron ›

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Lack of Assurance of Sterility: Complaints of syringe breakage

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Regeneron Pharmaceuticals is recalling approximately 405,725 single-dose prefilled syringes of EYLEA (aflibercept) injection. The recall addresses two serious issues: a lack of assurance that the product remains sterile and complaints regarding the glass syringe breaking during use. Because these are prescription medications administered via intravitreal injection, these defects pose significant health risks to patients. Read more at govinfonow.com/recall/32668-regeneron-recalls-eylea-injections-due-to-sterility-and-breakage-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/32668-regeneron-recalls-eylea-injections-due-to-sterility-and-breakage-risks · Updated October 9, 2026 · FDA enforcement record: FDA #D-0531-2024

Cite this page

“Regeneron Recalls EYLEA Injections Due to Sterility and Breakage Risks.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32668-regeneron-recalls-eylea-injections-due-to-sterility-and-breakage-risks. Based on FDA recall #D-0531-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0531-2024%22&limit=1).

The FDA announced on May 15, 2024, that Regeneron Pharmaceuticals Inc is recalling EYLEA injection syringes due to a lack of sterility assurance and complaints of syringe breakage. The recall affects 405,725 units distributed nationwide.

How to tell if you have it

Brand: Regeneron
Product: EYLEA Injection Syringe
NDC 61755-005-01
Lot # 8231500321, Exp. date Oct-24
Lot # 8231500335, Exp. date Jan-25
Lot # 8231500333, Exp. date Jan-25
Lot # 8231500334, Exp. date Jan-25
Lot # 8231500339, Exp. date Jan-25
Lot # 8231500347, Exp. date Jan-25
Lot # 8231500336, Exp. date Jan-25
Lot # 8231500337, Exp. date Jan-25
Lot # 8231500340, Exp. date Jan-25
Lot # 8268700014 (sample lot) exp. date Jan-25

The hazard

The recall is due to a lack of assurance of sterility and complaints of syringe breakage. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Regeneron Pharmaceuticals Inc has two other recalls on record since April 23, 2024. On July 28, 2026, Regeneron issued a Libtayo injection recall for lack of sterility assurance risk. On April 23, 2024, Regeneron recalled EYLEA Injection due to sterility and breakage risks. Other recent recalls of similar products include Reliance Pemetrexed Injection Recall (June 24, 2026) and Thea Pharma Similasan Eye Drops Recall (April 23, 2026).

How to tell if you have this one

Look for EYLEA (aflibercept) Injection, 2 mg in a single-dose prefilled glass syringe. Check the NDC 61755-005-01 and sample lot NDC 61755-005-54. Identify your specific unit by its Lot number (e.g., 8231500321, 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, 8231500336, 8231500337, 8231500340) and expiration date (Oct-24 or Jan-25). The sample lot NDC is 8268700014 with an exp. date of Jan-25.

Brand
Regeneron
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the syringe
Do not use any EYLEA syringes that match the recalled lot numbers or expiration dates listed in the record.
Contact your healthcare provider
Reach out to the doctor who prescribed the medication to report the recall and discuss next steps for your treatment.
Return or dispose of the product
The record does not specify a return address or disposal method, so follow your healthcare provider's instructions for handling the recalled item.

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 16 months after the firm started it.

May 15, 2024Firm started the recall
May 30, 2024FDA classified it Class II
Jun 5, 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.

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Link to this recall

<a href="https://govinfonow.com/recall/32668-regeneron-recalls-eylea-injections-due-to-sterility-and-breakage-risks">Regeneron Recalls EYLEA Injections 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-0531-2024 (May 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0531-2024 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.