Has Baxter Healthcare Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 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 2024-11-13; 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

Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…

Name: FDA Recall Record — Baxter Healthcare Corporation
Creator: Argus HQ
Published: 2024-11-13
License: https://argushq.ai/methodology

Event date: 2024-11-13 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: D-0039-2025
Payload hash: 13cbb01276f008c24cd1f154…

Summary

Labeling: Missing Label Status: Ongoing.

Entities

Baxter Healthcare Corporation

View source record ↗

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 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 2024-11-13; 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). Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0039-2025

MLA

"Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0039-2025.

Chicago

Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0039-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_d_0039_2025_2024,
  title = {Baxter Healthcare Corporation — Class II recall: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syri…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0039-2025},
  note = {Accessed: July 17, 2026}
}

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