WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the lot number and expiration date on the package before using the product. The U.S. Food and Drug Administration says specific lots of eight Rohto Cooling Eye Drops products have been recalled because of a “lack of assurance of sterility.”
The recall covers 11,960,623 cartons containing 12,460,649 bottles distributed nationwide, according to the FDA’s enforcement report. The products were sold over the counter and include single- and twin-pack versions of products such as All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief.
The concern does not mean that every bottle of those products is recalled. The FDA says consumers should compare the lot number and expiration date printed on their packaging with the agency’s official recall list.
What does “lack of assurance of sterility” mean?
Sterile eye drops are made to be free of microorganisms. The FDA’s wording means sterility cannot be assured for the affected products, so the drops could potentially be contaminated. The supplied FDA information does not identify a specific contaminant or say that contamination was confirmed.
The FDA classified the recall as Class II. Under the agency’s classification, a Class II product may cause temporary or medically reversible adverse health effects, while the probability of serious health consequences is considered remote.
The FDA information available for this recall does not identify a specific illness linked to the products. ABC10 reported that no illnesses had been reported, but the underlying agency record was not identified in the supplied information.
Which products are included?
The recall involves eight Rohto Cooling Eye Drops product varieties and certain lot numbers and package configurations. The affected products include versions marketed as All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief, according to FDA and manufacturer recall information.
Expiration dates are printed on the packaging. Because only specified lots are affected, the product name alone is not enough to determine whether a bottle is included.
The FDA’s enforcement information lists the products as manufactured in Vietnam and distributed by The Mentholatum Company. Rohto-Mentholatum initiated a voluntary recall on July 14, 2026, and the FDA classified it as Class II on July 23, 2026.
What should consumers do?
The FDA advises consumers who have an affected product to stop using it. The agency says the product can be disposed of or returned to the place of purchase.
Consumers should use the FDA’s recall list to check the product name, package configuration, lot number and expiration date. The available information does not identify a Washington, D.C.-specific retailer, health department action or reported case; the recall is nationwide.
