Reported Jun 5, 2024 · Terminated

EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled…

Regeneron Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Regeneron Pharmaceuticals Inc · 777 Old Saw Mill River Rd · Tarrytown, NY · 10591-6717

Is this the product you have?

  • EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only
  • Manufactured byRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54
Lot codes and dates
  • Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan-25 8231500339, Exp. date Jan-25 8231500347, Exp. date Jan-25 8231500336, Exp. date Jan-25 8231500337, Exp. date Jan-25 8231500340, Exp. date Jan-25 8268700014 (sample lot) exp. date Jan-25
Amount recalled
405,725 Prefilled syringes

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: Complaints of syringe breakage

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 25, 2025 · Data as of Sep 19, 3:29 PM UTC

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