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Drug FDA Class II Terminated Contamination / non-sterility

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 Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54

Regeneron Pharmaceuticals Inc Published Jun 5, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Regeneron Pharmaceuticals Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Complaints of syringe breakage

Hazards

Syringe Breakage · primaryLack of Sterility Assurance

Affected products (1)

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 Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54

EYLEA · 405,725 Prefilled syringes

NDC: 61755-005, 61755-005-02, 61755-005-55, 61755-005-01, 61755-005-54, 8231500321, 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, 8231500336, 8231500337, 8231500340, 8268700014
Lot codes: 8231500321
Code info: 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

Affected areas

Nationwide

Timeline

  1. Initiated
    May 15, 2024
  2. Published
    Jun 5, 2024
  3. Terminated
    Sep 25, 2025
Recall number
D-0531-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.