← FDA ENFORCEMENT
D-0531-2024Class II

Regeneron Pharmaceuticals Inc

Recalling firm
Regeneron Pharmaceuticals Inc
Product type
Drug
Status
Terminated
Report date
2024-06-05
Distribution
USA nationwide.
Firm state
NY
Product quantity
405,725 Prefilled syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Complaints of syringe breakage

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

Code / lot 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

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIOlympus Corporation of the Americas
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.