The Recall Desk
HighFDA (Drugs)·D-0531-2024·Announced 2024-06-05

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.

What this means for you

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
Hazard
  • sterility-failure
  • syringe-breakage

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.

Related recalls

Same brand · EYLEA

Same category