Has Viatris, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 18 total FDA actions tied to Viatris, 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 2023-06-14; 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

Viatris Inc — Class II recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo…

Name: FDA Recall Record — Viatris, Inc.
Creator: Argus HQ
Published: 2023-06-14
License: https://argushq.ai/methodology

Event date: 2023-06-14 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: D-0866-2023
Payload hash: b9540c443a129ca9fba6ffde…

Summary

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. Status: Terminated.

Entities

Viatris, Inc.

View source record ↗

Frequently asked questions

Has Viatris, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 18 total FDA actions tied to Viatris, 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 2023-06-14; 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). Viatris Inc — Class II recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-viatris-inc-d-0866-2023

MLA

"Viatris Inc — Class II recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-viatris-inc-d-0866-2023.

Chicago

Argus HQ Research. "Viatris Inc — Class II recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-viatris-inc-d-0866-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_viatris_inc_d_0866_2023_2023,
  title = {Viatris Inc — Class II recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-viatris-inc-d-0866-2023},
  note = {Accessed: July 23, 2026}
}

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