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 medium severity by Argus HQ. FDA published the underlying record on 2026-05-06; Argus observed and indexed it on 2026-07-09.

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 · medium

American Regent, Inc. — Class III recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i…

Name: FDA Recall Record — American Regent, Inc.
Creator: Argus HQ
Published: 2026-05-06
License: https://argushq.ai/methodology

Event date: 2026-05-06 00:00:00Z
Observed: 2026-07-09 22:51:44Z
Source ID: D-0494-2026
Payload hash: 0216d89efff2d8d0b76db16a…

Summary

Labeling: Missing Label 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 medium severity by Argus HQ. FDA published the underlying record on 2026-05-06; Argus observed and indexed it on 2026-07-09.
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 III recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-american-regent-inc-d-0494-2026

MLA

"American Regent, Inc. — Class III recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-american-regent-inc-d-0494-2026.

Chicago

Argus HQ Research. "American Regent, Inc. — Class III recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-american-regent-inc-d-0494-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_american_regent_inc_d_0494_2026_2026,
  title = {American Regent, Inc. — Class III recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-american-regent-inc-d-0494-2026},
  note = {Accessed: September 8, 2026}
}

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