Has American Regent, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 14 total FDA actions tied to American Regent, Inc.: 0 warning letters, 13 recalls, 0 approval records, and 1 Form 483 inspection citation.

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 2026-08-26; Argus observed and indexed it on 2026-09-08.

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

American Regent, Inc. — Class II recall: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use…

Name: FDA Recall Record — American Regent, Inc.
Creator: Argus HQ
Published: 2026-08-26
License: https://argushq.ai/methodology

Event date: 2026-08-26 00:00:00Z
Observed: 2026-09-08 04:20:21Z
Source ID: D-0793-2026
Payload hash: 0a1cffa1f4b0cec3c5683276…

Summary

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Status: Ongoing.

Entities

American Regent, Inc.

View source record ↗

Frequently asked questions

Has American Regent, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 14 total FDA actions tied to American Regent, Inc.: 0 warning letters, 13 recalls, 0 approval records, and 1 Form 483 inspection citation.
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 2026-08-26; Argus observed and indexed it on 2026-09-08.
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 (2026). American Regent, Inc. — Class II recall: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-american-regent-inc-d-0793-2026

MLA

"American Regent, Inc. — Class II recall: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-american-regent-inc-d-0793-2026.

Chicago

Argus HQ Research. "American Regent, Inc. — Class II recall: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-american-regent-inc-d-0793-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_american_regent_inc_d_0793_2026_2026,
  title = {American Regent, Inc. — Class II recall: Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-american-regent-inc-d-0793-2026},
  note = {Accessed: September 8, 2026}
}

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