Has Regeneron Pharmaceuticals Inc had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Regeneron Pharmaceuticals Inc: 0 warning letters, 3 recalls, 1 approval record, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-05-08; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · drug_recall · high

Regeneron Pharmaceuticals Inc — Class II recall: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…

Name: FDA Recall Record — Regeneron Pharmaceuticals Inc
Creator: Argus HQ
Published: 2024-05-08
License: https://argushq.ai/methodology

Event date: 2024-05-08 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0479-2024
Payload hash: 27bad89af74c5d651acfa8c3…

Summary

Lack of Assurance of Sterility: Complaints of syringe breakage Status: Terminated.

Entities

Regeneron Pharmaceuticals Inc

View source record ↗

Frequently asked questions

Has Regeneron Pharmaceuticals Inc had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Regeneron Pharmaceuticals Inc: 0 warning letters, 3 recalls, 1 approval record, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-05-08; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). Regeneron Pharmaceuticals Inc — Class II recall: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-regeneron-pharmaceuticals-inc-d-0479-2024

MLA

"Regeneron Pharmaceuticals Inc — Class II recall: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-regeneron-pharmaceuticals-inc-d-0479-2024.

Chicago

Argus HQ Research. "Regeneron Pharmaceuticals Inc — Class II recall: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-regeneron-pharmaceuticals-inc-d-0479-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_regeneron_pharmaceuticals_inc_d_0479_2024_2024,
  title = {Regeneron Pharmaceuticals Inc — Class II recall: EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-regeneron-pharmaceuticals-inc-d-0479-2024},
  note = {Accessed: September 8, 2026}
}

Informational only. Not legal, financial, or medical advice.