Has Huons Co., Ltd. had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd.: 1 warning letter, 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 2026-04-22; 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 · high

Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7…

Name: FDA Recall Record — Huons Co., Ltd.
Creator: Argus HQ
Published: 2026-04-22
License: https://argushq.ai/methodology

Event date: 2026-04-22 00:00:00Z
Observed: 2026-07-09 22:51:48Z
Source ID: D-0530-2026
Payload hash: f633ab0322f0874f72012c4d…

Summary

Lack of Assurance of Sterility Status: Ongoing.

Entities

Huons Co., Ltd.

View source record ↗

Frequently asked questions

Has Huons Co., Ltd. had other FDA enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to Huons Co., Ltd.: 1 warning letter, 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 2026-04-22; 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). Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-huons-co-ltd-d-0530-2026

MLA

"Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-huons-co-ltd-d-0530-2026.

Chicago

Argus HQ Research. "Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-huons-co-ltd-d-0530-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_huons_co_ltd_d_0530_2026_2026,
  title = {Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-huons-co-ltd-d-0530-2026},
  note = {Accessed: August 27, 2026}
}

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