WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the bottle and packaging against the U.S. Food and Drug Administration’s recall list before using the product. The FDA says nearly 12 million cartons containing more than 12.4 million bottles were distributed nationwide and may not be sterile.
The recall covers eight Rohto Cooling Eye Drops varieties, including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief. Some products were sold as single bottles and others in twin packs. The products were sold over the counter.
What is the concern?
The FDA lists the reason for the recall as a “lack of assurance of sterility.” In practical terms, that means the company and regulators cannot assure that the eye drops are free of microorganisms that could contaminate the product.
The FDA has not identified a specific contaminant or explained in the available recall information what caused the sterility concern. The recall applies only to specified lot numbers and expiration dates, not to every bottle of every Rohto product.
Lot numbers and expiration dates are printed on the packaging. The FDA says consumers should compare those details with the current recall list before deciding whether a bottle is affected.
What does Class II mean?
The FDA classified the recall as Class II. The agency defines a Class II recall as one involving products that may cause temporary or medically reversible adverse health consequences. The FDA also says the probability of serious adverse health consequences is remote.
That classification does not mean an affected product should continue to be used. It describes the agency’s assessment of the potential health risk across the recalled products.
What should consumers do?
The FDA advises consumers to stop using an affected bottle. Consumers can dispose of it or return it to the place of purchase, according to the agency’s recall guidance.
Anyone who has eye symptoms after using an affected product should contact a health professional. The FDA’s recall information does not provide a specific treatment recommendation for symptoms.
The recall was initiated voluntarily by Rohto-Mentholatum on July 14, 2026, according to manufacturer recall information. The FDA classified it on July 23, 2026. The products were manufactured in Vietnam and distributed by The Mentholatum Company.
The FDA’s enforcement report lists 11,960,623 cartons containing 12,460,649 bottles. Because the recall covers particular lots and package configurations, the total number of affected bottles is not the same as the number of individual product varieties.
The FDA’s recall database and enforcement report provide the product names, lot numbers and expiration dates needed to identify affected bottles. Consumers should use those records rather than relying only on the product name or a general expiration-date range.
