Has Huons Co., Ltd. had product recalls?

Yes, 4 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Huons Co., Ltd. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Huons Co., Ltd. had?

Argus HQ has recorded 5 FDA events for Huons Co., Ltd.: 1 warning letters, 4 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Huons Co., Ltd.?

The most recent FDA event Argus HQ has on file for Huons Co., Ltd. is dated 2026-06-15, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

FDA Actions Against Huons Co., Ltd.

Here's the summary: Argus HQ has recorded 5 FDA events for Huons Co., Ltd.: 1 warning letters, 4 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-04-22 to 2026-06-15. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	5
Warning letters	1
Recalls	4
Approval records	0
Form 483 inspection citations	0
Most recent action	June 15, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Huons Co., Ltd. has both FDA warning letters and recalls on file, which may suggest quality-system issues that surfaced in more than one FDA process. Huons Co., Ltd. has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-04-22, Argus HQ recorded a FDA recall for Huons Co., Ltd., rated "high" severity in Argus HQ's classification: Huons Co., Ltd. — Class II recall: Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials,… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Huons Co., Ltd., rated "high" severity in Argus HQ's classification: Huons Co., Ltd. — Class II recall: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preser… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Huons Co., Ltd., rated "high" severity in Argus HQ's classification: Huons Co., Ltd. — Class II recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-22, Argus HQ recorded a FDA recall for Huons Co., Ltd., rated "high" severity in Argus HQ's classification: Huons Co., Ltd. — Class II recall: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-15, Argus HQ recorded a FDA Warning Letter for Huons Co., Ltd., rated "critical" severity in Argus HQ's classification: Huons Co., Ltd. — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-15) An FDA Warning Letter is FDA's formal notice that inspectors found significant violations requiring prompt correction. In total, Huons Co., Ltd. has 5 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

Has Huons Co., Ltd. had product recalls?: Yes, 4 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Huons Co., Ltd. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Huons Co., Ltd. had?: Argus HQ has recorded 5 FDA events for Huons Co., Ltd.: 1 warning letters, 4 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Huons Co., Ltd.?: The most recent FDA event Argus HQ has on file for Huons Co., Ltd. is dated 2026-06-15, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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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). FDA Actions Against Huons Co., Ltd.. Digital Empire LLC. Retrieved from https://argushq.ai/company/huons-co-ltd

MLA

"FDA Actions Against Huons Co., Ltd.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/huons-co-ltd.

Chicago

Argus HQ Research. "FDA Actions Against Huons Co., Ltd.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/huons-co-ltd.

BibTeX

@misc{argushq_argushq_ai_company_huons_co_ltd_2026,
  title = {FDA Actions Against Huons Co., Ltd.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/huons-co-ltd},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗