Regeneron Pharmaceuticals Eylea Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility: Complaints of syringe breakage

Product description

EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01

Lot numbers, UPCs & expiration codes

Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25

Where it was sold

USA Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0479-2024
Classification: Class II
Status: Terminated
Recall initiated: Apr 23, 2024
FDA report date: May 8, 2024
Quantity: 251,504 syringes
Recall type: Voluntary: Firm initiated
Recalling firm: Regeneron Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0479-2024, exactly as published.

Show all FDA fields

City: Tarrytown
State: NY
Status: Terminated
Country: United States
Event ID: 94481
Address: 777 Old Saw Mill River Rd
Code information: Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
Postal code: 10591-6717
Report date: May 8, 2024
Product type: Drugs
Recall number: D-0479-2024
Classification: Class II
Recalling firm: Regeneron Pharmaceuticals Inc
Product quantity: 251,504 syringes
Termination date: Sep 25, 2025
Reason for recall: Lack of Assurance of Sterility: Complaints of syringe breakage
Voluntary / mandated: Voluntary: Firm initiated
Product description: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01
Distribution pattern: USA Nationwide
Recall initiation date: Apr 23, 2024
Initial firm notification: E-Mail
Center classification date: May 2, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0479-2024, published May 8, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Regeneron Pharmaceuticals Eylea Recall

Summary