# FDA recall D-0531-2024

> **Regeneron Pharmaceuticals Inc** · Class II · drug recall initiated 2024-05-15.

## 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

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0531-2024
- **Recalling firm:** Regeneron Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-15
- **Report date:** 2024-06-05
- **Termination date:** 2025-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0531-2024

## Citation

> AI Analytics. FDA recall D-0531-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0531-2024. Source: US FDA. Licensed CC0.

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