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 2024-07-03; 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: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…

Name: FDA Recall Record — PFIZER INC
Creator: Argus HQ
Published: 2024-07-03
License: https://argushq.ai/methodology

Event date: 2024-07-03 00:00:00Z
Observed: 2026-07-16 23:19:23Z
Source ID: D-0565-2024
Payload hash: 71fc6b2254c45f1a171d5ea1…

Summary

Lack of Assurance of Sterility-The potential for incomplete crimp seals. 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 2024-07-03; 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). Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-pfizer-inc-d-0565-2024

MLA

"Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-pfizer-inc-d-0565-2024.

Chicago

Argus HQ Research. "Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-pfizer-inc-d-0565-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_pfizer_inc_d_0565_2024_2024,
  title = {Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-pfizer-inc-d-0565-2024},
  note = {Accessed: July 23, 2026}
}

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