Eylea Injection, Solution
FDA Recall NDC 61755-005
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Eylea (NDC 61755-005). A significant event, classified as Class II, was initiated on May 15, 2024 by Regeneron Pharmaceuticals, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Complaints of syringe breakage"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Complaints of syringe breakage
May 15, 2024
Jun 05, 2024
405,725 Prefilled syringes
Recall Profile & Regulatory Data
Event ID
94646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Regeneron Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Sep 25, 2025
Product Description
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
Batch or Lot Expiration Information
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 Packages Involved in this Recall
61755-005-02Product
61755-005-55Product
61755-005-01Product
61755-005-54Product
8231500321Product
8231500335Product
8231500333Product
8231500334Product
8231500339Product
8231500347Product
8231500336Product
8231500337Product
8231500340Product
8268700014Product
Class II Terminated
Lack of Assurance of Sterility: Complaints of syringe breakage
Apr 23, 2024
May 08, 2024
251,504 syringes
Recall Profile & Regulatory Data
Event ID
94481
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Regeneron Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Sep 25, 2025
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
Batch or Lot Expiration Information
Lot# 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
Affected Packages Involved in this Recall
61755-005-02Product
61755-005-55Product
61755-005-01Product
61755-005-54Product
8231500321Product
8231500335Product
8231500333Product
8231500334Product
8231500339Product
8231500347Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
