WASHINGTON, Aug. 3 (DC Times Online) — Consumers who use Rohto Cooling Eye Drops should check the bottle or carton before using it. The U.S. Food and Drug Administration says specific lots of eight Rohto Cooling Eye Drops products were recalled because of a “lack of 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 nationwide. The Mentholatum Company distributed the products, which were manufactured in Vietnam.
The FDA classified the recall as Class II. That category means use of the affected products may cause temporary or medically reversible health effects, while the probability of serious health consequences is considered remote, according to the FDA’s classification description.
Which products are affected?
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 as single bottles and others in twin packs.
The recall applies only to specified lot numbers and expiration dates. It does not include every bottle of every Rohto product with one of those names. Lot numbers and expiration dates are printed on the package. The FDA’s recall list contains the affected combinations.
Because product names and package types can be similar, consumers should compare both the lot number and expiration date with the FDA’s list rather than relying only on the brand or product name.
What does “lack of assurance of sterility” mean?
Eye drops are intended to be sterile, meaning they should not contain microorganisms that could cause an infection. The FDA’s wording means sterility could not be assured for the recalled products. The recall information does not identify a specific organism or say that contamination was confirmed.
The FDA’s Class II rating does not mean the products are considered risk-free. It indicates that any potential harm is generally expected to be temporary or medically reversible and that serious harm is unlikely or remote.
What should consumers do?
The FDA advises consumers who have an affected product to stop using it. The product may be disposed of or returned to the place of purchase, according to the agency’s recall guidance.
People who have used a recalled product and are concerned about symptoms should contact a health care professional. The supplied FDA recall information does not identify a specific symptom list or provide evidence of a confirmed illness tied to the recalled lots.
The voluntary recall was initiated by Rohto-Mentholatum on July 14, 2026, according to manufacturer recall information cited in the FDA-related reports. The FDA classified the recall on July 23, 2026.
The FDA’s recall database and enforcement report are the authoritative sources for the affected lot numbers, expiration dates and package descriptions. Consumers should check those records before deciding whether a bottle is included.
