Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL
Recalled July 29, 2026 · FDA recall D-0717-2026 · Rohto-Mentholatum (Vietnam)
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
499,673 cartons
Sold at
Nationwide within the United States
Description
Lack of Assurance of Sterility
Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Manufacturer(s)
Rohto-Mentholatum (Vietnam) Co., Ltd.
Made in
Vietnam
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →