How many FDA actions does Argus HQ track for Rohto-Mentholatum (Vietnam) Co., Ltd.?

8 total: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Rohto-Mentholatum (Vietnam) Co., Ltd.?

July 29, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Rohto-Mentholatum (Vietnam) Co., Ltd. had product recalls?

Yes, 8 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Rohto-Mentholatum (Vietnam) 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.

Rohto-Mentholatum (Vietnam) Co., Ltd.'s Complete FDA Record

FDA action counts

Total FDA actions	8
Warning letters	0
Recalls	8
Approval records	0
Form 483 inspection citations	0
Most recent action	July 29, 2026

In short: Argus HQ has recorded 8 FDA events for Rohto-Mentholatum (Vietnam) Co., Ltd.: 0 warning letters, 8 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-07-29 to 2026-07-29. The most severe rating Argus HQ has assigned across this history is "high". 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. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Rohto-Mentholatum (Vietnam) Co., Ltd. has 8 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. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorba…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorba…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorba…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%…. On 2026-07-29, Argus HQ recorded an FDA recall for Rohto-Mentholatum (Vietnam) Co., Ltd., rated "high" severity in Argus HQ's classification: Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05….

Frequently asked questions

How many FDA actions does Argus HQ track for Rohto-Mentholatum (Vietnam) Co., Ltd.?: 8 total: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Rohto-Mentholatum (Vietnam) Co., Ltd.?: July 29, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Rohto-Mentholatum (Vietnam) Co., Ltd. had product recalls?: Yes, 8 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Rohto-Mentholatum (Vietnam) 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.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jul 29, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Rohto-Mentholatum (Vietnam) Co., Ltd.'s Complete FDA Record. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/rohto-mentholatum-vietnam-co-ltd

MLA

"Rohto-Mentholatum (Vietnam) Co., Ltd.'s Complete FDA Record." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/rohto-mentholatum-vietnam-co-ltd.

Chicago

Argus HQ Research. "Rohto-Mentholatum (Vietnam) Co., Ltd.'s Complete FDA Record." Digital Empire Holdings LLC. Accessed August 4, 2026. https://argushq.ai/company/rohto-mentholatum-vietnam-co-ltd.

BibTeX

@misc{argushq_argushq_ai_company_rohto_mentholatum_vietnam_co_ltd_2026,
  title = {Rohto-Mentholatum (Vietnam) Co., Ltd.'s Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/rohto-mentholatum-vietnam-co-ltd},
  note = {Accessed: August 4, 2026}
}

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