Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Eylea (Aflibercept)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Complaints of syringe breakage
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
61755-0005-01
Compare with the code on your package — it is the most precise check available.
Drug: Aflibercept
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Eylea aflibercept NDC 61755-0005 |
40 mg/mL | Injection, Solution Intravitreal |
Regeneron Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Regeneron Pharmaceuticals Inc
- NDC code
- 61755-005-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0479-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aflibercept recalls
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Class II · Moderate risk
Aflibercept
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by Regeneron Pharmaceuticals Inc
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Libtayo (cemiplimab-rwlc)
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Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
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All sterility / contamination recalls
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Class I · High risk
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Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
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