FDA Drug recall D-0531-2024
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx o…
- FDA Drug
- Class II
- terminated
- Published 2024-06-05
On 2024-06-05 the FDA classified a Class II recall of EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx o… by Regeneron Pharmaceuticals, citing lack of Assurance of Sterility: Complaints of syringe breakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0531-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-15 |
| Published | 2024-06-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Regeneron Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Lack of Assurance of Sterility: Complaints of syringe breakage
Identifiers
| ndc | 61755-005-02 |
|---|---|
| ndc | 61755-005-55 |
| ndc | 61755-005-01 |
| ndc | 61755-005-54 |
| ndc | 8231500321 |
| ndc | 8231500335 |
| ndc | 8231500333 |
| ndc | 8231500334 |
| ndc | 8231500339 |
| ndc | 8231500347 |
| ndc | 8231500336 |
| ndc | 8231500337 |
| ndc | 8231500340 |
| ndc | 8268700014 |
| code_info | Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0531-2024%22
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