Has PFIZER INC had other FDA enforcement actions?

Yes. Argus HQ has recorded 18 total FDA actions tied to PFIZER INC: 0 warning letters, 18 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 2025-07-02; 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

Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…

Name: FDA Recall Record — PFIZER INC
Creator: Argus HQ
Published: 2025-07-02
License: https://argushq.ai/methodology

Event date: 2025-07-02 00:00:00Z
Observed: 2026-07-16 23:19:23Z
Source ID: D-0489-2025
Payload hash: 8f6012d12d9e3199a3eba9e0…

Summary

Discoloration; discolored solution from cracked vials Status: Ongoing.

Entities

PFIZER INC

View source record ↗

Frequently asked questions

Has PFIZER INC had other FDA enforcement actions?: Yes. Argus HQ has recorded 18 total FDA actions tied to PFIZER INC: 0 warning letters, 18 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 2025-07-02; 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). Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-pfizer-inc-d-0489-2025

MLA

"Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-pfizer-inc-d-0489-2025.

Chicago

Argus HQ Research. "Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-pfizer-inc-d-0489-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_pfizer_inc_d_0489_2025_2025,
  title = {Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-pfizer-inc-d-0489-2025},
  note = {Accessed: July 23, 2026}
}

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