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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Eylea (aflibercept) Injection Recalled for Syringe Breakage and Sterility Risk

Agency Publication Date: May 30, 2024
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Summary

Regeneron Pharmaceuticals Inc. is recalling approximately 405,725 units of EYLEA (aflibercept) Injection, 2 mg (0.05mL), provided in single-dose pre-filled glass syringes. The recall was initiated following reports of syringe breakage, which leads to a lack of assurance of sterility for the medication. Because this drug is administered by intravitreal injection (directly into the eye), any compromise in the syringe's integrity or sterility poses a serious risk to patient safety.

Risk

A broken syringe or a lack of sterility can lead to serious eye infections, such as endophthalmitis, or other complications that could potentially impact a patient's vision.

What You Should Do

  1. This recall involves EYLEA (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), provided in single-dose pre-filled glass syringes (NDC 61755-005-01 and NDC 61755-005-54).
  2. Check the product packaging for the following affected lot numbers: 8231500321 (Exp. Oct-24), 8231500335 (Exp. Jan-25), 8231500333 (Exp. Jan-25), 8231500334 (Exp. Jan-25), 8231500339 (Exp. Jan-25), 8231500347 (Exp. Jan-25), 8231500336 (Exp. Jan-25), 8231500337 (Exp. Jan-25), 8231500340 (Exp. Jan-25), and 8268700014 (Exp. Jan-25).
  3. Stop using the recalled product. Contact Regeneron Pharmaceuticals Inc. or your distributor to arrange for the return of any unused syringes from the affected lots.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: EYLEA (aflibercept) Injection (2 mg / 0.05mL)
Variants: 2 mg, 0.05mL of a 40mg/mL solution, Single-dose Pre-filled Glass Syringe
Lot Numbers:
8231500321 (Exp. Oct-24)
8231500335 (Exp. Jan-25)
8231500333 (Exp. Jan-25)
8231500334 (Exp. Jan-25)
8231500339 (Exp. Jan-25)
8231500347 (Exp. Jan-25)
8231500336 (Exp. Jan-25)
8231500337 (Exp. Jan-25)
8231500340 (Exp. Jan-25)
8268700014 (Exp. Jan-25)
NDC:
61755-005-01
61755-005-54

Rx only; Manufactured by Regeneron Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94646
Status: Resolved
Manufacturer: Regeneron Pharmaceuticals Inc
Sold By: Wholesalers; Specialty Distributors; Medical Facilities
Manufactured In: United States
Units Affected: 405,725 Prefilled syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.