WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the lot number and expiration date on the bottle before using it. The U.S. Food and Drug Administration has announced a nationwide recall covering nearly 12 million bottles because the products lack assurance of sterility.
The recall covers 11,960,623 cartons containing 12,460,649 bottles, according to the FDA’s enforcement report. The products were sold over the counter, and the affected expiration dates range from July 2025 through February 2029.
The FDA says the concern does not mean contamination was confirmed in every recalled bottle. Rather, “lack of assurance of sterility” means the agency cannot be certain that the products are free of microorganisms. Eye drops are placed directly in the eye, so sterile manufacturing and packaging are important.
Which products are included?
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 are sold as single bottles and others in twin packs.
The FDA’s recall list identifies the specific lot numbers and expiration dates affected. Not every bottle of a named Rohto product is part of the recall. Consumers should compare the information on their packaging with the FDA’s online recall listing rather than relying only on the product name.
What does Class II mean?
The FDA classified the recall as Class II. The agency uses that category when a product may cause temporary or medically reversible health effects, while the probability of serious adverse health consequences is considered remote.
That classification describes the FDA’s assessment of the recall risk; it does not identify a confirmed illness or infection in a particular consumer. The FDA information available for this recall does not specify what caused the sterility concern or say that contamination was found in every product.
What should consumers do?
The FDA advises consumers to stop using a recalled product. They may dispose of it or return it to the place of purchase.
Consumers who develop eye symptoms after using an affected product should contact a health care professional, who can evaluate their symptoms and provide medical advice. The FDA also accepts reports of problems involving medical products through its MedWatch program.
The voluntary recall was initiated by Rohto-Mentholatum on July 14, 2026, and the FDA classified it as Class II on July 23, 2026. The products were manufactured in Vietnam and distributed by The Mentholatum Company, according to recall information cited by the FDA. The products were distributed nationwide, including to consumers in Washington, D.C.
