EYLEA injectable eye medication recalled due to sterility and syringe breakage
Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug with potential for serious harm through sterility failure and device malfunction. In the absence of any reported illnesses or injuries, the hazard remains unconfirmed in terms of actual patient harm, limiting the severity to High per the rubric.
Plain-English summary
Regeneron Pharmaceuticals Inc. is recalling 405,725 prefilled syringes of EYLEA (aflibercept) 2 mg intravitreal injection, a medication used to treat eye conditions. The recall affects multiple lots with expiration dates ranging from October 2024 to January 2025, distributed nationwide in the United States.
The recall was initiated due to lack of assurance of sterility and complaints of syringe breakage. Because this product is injected directly into the eye, a loss of sterility could pose a significant health risk. The syringe breakage complaints indicate potential quality control issues with the delivery system that could affect proper drug administration or patient safety.
Patients who have received this medication or have syringes from the affected lots should contact their healthcare provider or ophthalmologist immediately to verify whether their product is from a recalled lot. Healthcare providers should check the lot numbers and expiration dates provided by the FDA and follow guidance on proper handling of recalled stock.
The recalled product
- Product
- EYLEA (AFLIBERCEPT)
- Brand
- EYLEA
- Manufacturer
- Regeneron Pharmaceuticals Inc
- Category
- Drug — Ophthalmic Injection
- Affected units
- 405,725
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
UPCs (1)
- 258231500336
Distribution
Distributed nationwide across the United States.
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