EYLEA — Class II drug recall D-0531-2024
Terminated recall by Regeneron Pharmaceuticals Inc, reported 2024-06-05, distributed nationwide. Lack of Assurance of Sterility: Complaints of syringe breakage
| Recall number | D-0531-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Regeneron Pharmaceuticals Inc, Tarrytown, NY, United States |
| Recall initiated | 2024-05-15 |
| Classified | 2024-05-30 |
| Reported by FDA | 2024-06-05 |
| Terminated | 2025-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 405,725 prefilled |
| Reason classes | sterility, device malfunction |
| NDC | 61755-0005, 61755-0005-01, 61755-0005-02, 61755-0005-54, 61755-0005-55 |
| Lot numbers | 61755-005-54, 8231500321, 8231500333, 8231500334, 8231500335, 8231500336, 8231500337, 8231500339, 8231500340, 8231500347, 8268700014, JAN-25, OCT-24 |
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 for recall
Lack of Assurance of Sterility: Complaints of syringe breakage
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0531-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.