Has AbbVie Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to AbbVie Inc.: 0 warning letters, 4 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 2024-10-02; 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

AbbVie Inc. — Class II recall: Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment…

Name: FDA Recall Record — AbbVie Inc.
Creator: Argus HQ
Published: 2024-10-02
License: https://argushq.ai/methodology

Event date: 2024-10-02 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0664-2024
Payload hash: 2fb0312cb5e057bba9b4dac9…

Summary

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Status: Ongoing.

Entities

AbbVie Inc.

View source record ↗

Frequently asked questions

Has AbbVie Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to AbbVie Inc.: 0 warning letters, 4 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 2024-10-02; 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 (2024). AbbVie Inc. — Class II recall: Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbvie-inc-d-0664-2024

MLA

"AbbVie Inc. — Class II recall: Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbvie-inc-d-0664-2024.

Chicago

Argus HQ Research. "AbbVie Inc. — Class II recall: Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbvie-inc-d-0664-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbvie_inc_d_0664_2024_2024,
  title = {AbbVie Inc. — Class II recall: Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbvie-inc-d-0664-2024},
  note = {Accessed: July 23, 2026}
}

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