EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solu… recall
FDA recall D-0531-2024 · initiated May 15, 2024
Regeneron Pharmaceuticals Inc recalled EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… in May 2024 — an FDA Class II recall (D-0531-2024) because Lack of Assurance of Sterility: Complaints of syringe breakage.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Complaints of syringe breakage
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 405,725 Prefilled syringes
Details
- 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
- Recalling company
- Regeneron Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- May 15, 2024
- FDA report date
- Jun 5, 2024
Frequently asked
- Was EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… recalled?
- Regeneron Pharmaceuticals Inc recalled EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… in May 2024 — an FDA Class II recall (D-0531-2024) because Lack of Assurance of Sterility: Complaints of syringe breakage. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… recalled?
- Per the FDA enforcement record, the reason for recall D-0531-2024 was: Lack of Assurance of Sterility: Complaints of syringe breakage
- Is a recalled EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40… are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan-25 8231500339, Exp. date Jan-25 8231500347, Exp. date Jan-25 8231500336, Exp. date Jan-25 8231500337, Exp. date Jan-25 8231500340, Exp. date Jan-25 8268700014 (sample lot) exp. date Jan-25. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0531-2024.