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fda_recall · drug_recall · high

Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…

Event date
2023-10-25 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
D-0048-2024
Payload hash
39d7b86c221ed5dc52d430dc

Summary

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. Status: Terminated.

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 2023-10-25; 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 (2023). Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0048-2024
MLA
"Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0048-2024.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0048-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_d_0048_2024_2023,
  title = {Baxter Healthcare Corporation — Class II recall: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), S…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-d-0048-2024},
  note = {Accessed: July 23, 2026}
}

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