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

Yes. Argus HQ has recorded 15 total FDA actions tied to American Regent, Inc.: 0 warning letters, 14 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 critical severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-29.

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 · critical

American Regent, Inc. — Class I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…

Name: FDA Recall Record — American Regent, Inc.
Creator: Argus HQ
Published: 2026-09-16
License: https://argushq.ai/methodology

Event date: 2026-09-16 00:00:00Z
Observed: 2026-09-29 04:20:26Z
Source ID: D-0865-2026
Payload hash: 8705cdf8cdeed195790a57d1…

Summary

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. 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 15 total FDA actions tied to American Regent, Inc.: 0 warning letters, 14 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 critical severity by Argus HQ. FDA published the underlying record on 2026-09-16; Argus observed and indexed it on 2026-09-29.
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 I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-american-regent-inc-d-0865-2026

MLA

"American Regent, Inc. — Class I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-american-regent-inc-d-0865-2026.

Chicago

Argus HQ Research. "American Regent, Inc. — Class I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-american-regent-inc-d-0865-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_american_regent_inc_d_0865_2026_2026,
  title = {American Regent, Inc. — Class I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-american-regent-inc-d-0865-2026},
  note = {Accessed: September 29, 2026}
}

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