CLASS II Drug recall · Reported 8 May 2024 · FDA Enforcement Report
Eylea, (aflibercept) Injection, 2 mg of a 40mg/mL solution) recalled
Regeneron Pharmaceuticals is recalling Eylea, (aflibercept) Injection, 2 mg of a 40mg/mL solution), Single-dose Pre-filled, distributed nationwide in the US. The recall was initiated on 23 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0479-2024
- FDA event ID
- 94481
- Recalling firm
- Regeneron Pharmaceuticals, Tarrytown, NY
- Brand
- Eylea
- Manufacturer
- Regeneron Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2024
- FDA classified
- 2 May 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Apr 2024 | Recall initiated by company | |
| 2 May 2024 | Classified by FDA | +9 days |
| 8 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Complaints of syringe breakage
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Complaints of syringe breakage
Which lots are affected?
Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Regeneron Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Libtayo (cemiplimab-rwlc) Injection, 350 mg/ (50 mg/mL) recalledLibtayo | Regeneron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eylea, (aflibercept) Injection, For Intravitreal injection recalledEylea | Regeneron Pharmaceuticals | Sterility | Nationwide |
Other Aflibercept recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Eylea, (aflibercept) Injection, For Intravitreal injection recalledEylea | Regeneron Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Aflibercept, Sdpf - Syringe, 5/16") 40mg/ML Injectable recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |