WASHINGTON, Aug. 3 (DC Times Online) — People who use Rohto Cooling Eye Drops should check the lot number and expiration date on the bottle or carton before using the product. The Food and Drug Administration says specific lots of eight Rohto Cooling Eye Drops products were recalled because the company could not assure that the products were sterile.
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 nationwide, including through retailers that serve consumers in Washington, D.C.
What does “lack of assurance of sterility” mean?
Sterile eye drops are made to be free of microorganisms. The FDA’s stated reason for the recall — “lack of assurance of sterility” — means sterility cannot be assured and the products could potentially contain microorganisms. The available recall information does not say that contamination was confirmed or identify a specific microorganism.
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 harm is considered remote. The classification does not mean every bottle is contaminated or that every person who used a recalled product will become ill.
Which products are included?
The recall involves 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 in single- and twin-pack configurations.
Only specified lots are affected. Consumers should compare the lot number and expiration date on their packaging with the FDA’s official recall list rather than assume that every bottle in one of the named product lines is included.
The supplied recall reports agree that affected products have expiration dates extending through February 2029, but they differ about the earliest expiration date. Some list July 2025, while others list July 2026. The FDA recall list is the controlling source for checking a particular bottle.
What should consumers do?
The FDA advises consumers who have an affected product to stop using it. The agency says the product may be disposed of or returned to the place of purchase.
Consumers should keep the packaging while checking the lot number, because the product name alone is not enough to determine whether a bottle is recalled. Retailers and consumers can use the FDA’s enforcement database and recall information to compare the complete product details.
Rohto-Mentholatum reportedly initiated the voluntary recall on July 14, 2026. 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 manufacturer and FDA recall information.
The recall information supplied for this report does not identify a Washington, D.C.-specific retailer, distribution center or reported illness. It describes the action as nationwide.
