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fda_recall · drug_recall · high

Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05…

Event date
2026-07-29 00:00:00Z
Observed
2026-08-04 04:20:46Z
Source ID
D-0715-2026
Payload hash
267c6e60ea0b3814e3fd3919

Summary

Lack of Assurance of Sterility Status: Ongoing.

Frequently asked questions

Has Rohto-Mentholatum (Vietnam) Co., Ltd. had other FDA enforcement actions?
Yes. Argus HQ has recorded 8 total FDA actions tied to Rohto-Mentholatum (Vietnam) Co., Ltd.: 0 warning letters, 8 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 2026-07-29; Argus observed and indexed it on 2026-08-04.
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). Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-rohto-mentholatum-vietnam-co-ltd-d-0715-2026
MLA
"Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-rohto-mentholatum-vietnam-co-ltd-d-0715-2026.
Chicago
Argus HQ Research. "Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05…." Digital Empire Holdings LLC. Accessed August 4, 2026. https://argushq.ai/events/fda-recall-rohto-mentholatum-vietnam-co-ltd-d-0715-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_rohto_mentholatum_vietnam_co_ltd_d_0715_2026_2026,
  title = {Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II recall: Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-rohto-mentholatum-vietnam-co-ltd-d-0715-2026},
  note = {Accessed: August 4, 2026}
}

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