FDA Drug recall D-0479-2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Ph…
- FDA Drug
- Class II
- terminated
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Ph… 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-0479-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-04-23 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Regeneron Pharmaceuticals |
| Distribution | US |
Product
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
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 |
| code_info | Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25 |
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-0479-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.