Has Amgen, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to Amgen, Inc.: 0 warning letters, 7 recalls, 0 approval records, 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 2025-03-26; 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

Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl…

Name: FDA Recall Record — Amgen, Inc.
Creator: Argus HQ
Published: 2025-03-26
License: https://argushq.ai/methodology

Event date: 2025-03-26 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0285-2025
Payload hash: 10493c7a7159f829db07e0a8…

Summary

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. Status: Ongoing.

Entities

Amgen, Inc.

View source record ↗

Frequently asked questions

Has Amgen, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to Amgen, Inc.: 0 warning letters, 7 recalls, 0 approval records, 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 2025-03-26; 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 (2025). Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-amgen-inc-d-0285-2025

MLA

"Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-amgen-inc-d-0285-2025.

Chicago

Argus HQ Research. "Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-amgen-inc-d-0285-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_amgen_inc_d_0285_2025_2025,
  title = {Amgen, Inc. — Class II recall: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Onl…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-amgen-inc-d-0285-2025},
  note = {Accessed: July 23, 2026}
}

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