Class II

Drug Recall: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietn

Rohto-Mentholatum (Vietnam) Co., Ltd. · July 14, 2026

Reason for Recall

Lack of Assurance of Sterility

Product Description

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

6076306 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0716-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.