Warning
Rohto-Mentholatum (Vietnam) Co. Recalls Rohto Cooling Eye Drops Dry Aid
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0721-2026Drug / Pharmaceutical
Rohto-Mentholatum (Vietnam) Co. Recalls Rohto Cooling Eye Drops Dry Aid
Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II — Moderate Risk
Product Description
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Rohto-Mentholatum (Vietnam) Co., Ltd., initiated on July 14, 2026. Lack of Assurance of Sterility. This recall covers 353 cartons, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.