EYLEA injection recalled for sterility concerns and syringe breakage complaints
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
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: FDA Class II recall of an injectable medication with reported sterility assurance concerns and syringe breakage complaints. No illnesses or injuries have been reported in the source material, warranting a High rating rather than Severe.
Plain-English summary
Regeneron Pharmaceuticals, Inc. is recalling 251,504 single-dose pre-filled syringes of EYLEA (aflibercept) Injection, 2 mg. The recall was initiated due to lack of assurance of sterility and complaints of syringe breakage reported for specific manufacturing lots.
Affected lots include Lot #8231500321 (expiration 10/31/24) and lots #8231500335, 8231500333, 8231500334, 8231500339, and 8231500347 (all expiring 1/30/25). These syringes were distributed nationwide in the United States.
The recall addresses concerns about sterility assurance and reports of syringe breakage. Further information regarding this recall is available through the FDA and Regeneron Pharmaceuticals.
The recalled product
- Product
- EYLEA (AFLIBERCEPT)
- Brand
- EYLEA
- Manufacturer
- Regeneron Pharmaceuticals Inc
- Category
- Drug — Ophthalmologic Injectable
- Affected units
- 251,504
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 (8)
- Lot # 8231500321
- Exp 10/31 24
- 8231500335
- 8231500333
- 8231500334
- 8231500339
- 8231500347
- Exp 1/30/25
Distribution
Distributed nationwide across the United States.
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