Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL O
Recalled July 29, 2026 · FDA recall D-0715-2026 · Rohto-Mentholatum (Vietnam)
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
1.033,266 cartons
Sold at
Nationwide within the United States
Description
Lack of Assurance of Sterility
Product
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
Manufacturer(s)
Rohto-Mentholatum (Vietnam) Co., Ltd.
Made in
Vietnam
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →