WASHINGTON, Aug. 3 (DC Times Online) — Consumers in Washington, D.C., and across the country should check the lot number and expiration date on certain Rohto Cooling Eye Drops before using them. The U.S. Food and Drug Administration says nearly 12 million cartons — containing 12,460,649 bottles — are part of a recall because sterility cannot be assured.
The recall covers eight Rohto Cooling Eye Drops varieties sold over the counter nationwide. The affected products include All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief, along with single- and twin-pack versions. The FDA’s recall information lists expiration dates ranging from July 2025 through February 2029.
Not every bottle of those products is recalled. The FDA says only specified lot numbers and expiration dates are affected, so consumers should compare the information on their packaging with the agency’s official recall list.
What does “lack of assurance of sterility” mean?
Eye drops are intended to be sterile, meaning they should not contain microorganisms such as bacteria or fungi. The FDA describes the reason for this recall as a “lack of assurance of sterility.” That means the products’ sterility could not be assured and that contamination is possible; the available information does not establish that every recalled bottle is contaminated.
The FDA has classified the recall as Class II. Under the agency’s definition, a Class II product may cause temporary or medically reversible health effects, while the probability of serious harm is considered remote.
The supplied recall information does not identify the specific problem that led to the sterility concern.
What should consumers do?
The FDA advises consumers who have an affected product to stop using it. The product can be disposed of or returned to the store where it was purchased, according to the agency’s recall guidance.
Because the recall is based on lot numbers and expiration dates, consumers should not rely only on the product name or package design. They should check the FDA recall list and compare it with the information printed on the bottle or carton.
Anyone concerned about symptoms after using eye drops should contact a health care professional. The FDA also accepts reports of suspected problems through its MedWatch reporting program.
How did the recall begin?
Rohto-Mentholatum initiated a voluntary recall on July 14, 2026, according to manufacturer recall information. The FDA classified the recall as Class II on July 23, 2026.
The products were manufactured in Vietnam and distributed by The Mentholatum Company. The FDA says they were distributed nationwide, so the recall may affect products sold by retailers in the District of Columbia as well as elsewhere in the United States.
No Washington, D.C.-specific illnesses, retailer actions or health department response were identified in the information available for this report.
