⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Rohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholat

DrugsSource: FDA (drug) · Date: 2026-07-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Rohto-Mentholatum (Vietnam) Co., Ltd.
Product
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-07-14
Code info
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Product quantity
65219 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Ho Chi Minh
State
N/A
Country
Vietnam
Event id
99440
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