The U.S. Food and Drug Administration announced a voluntary recall of eight Rohto Cooling Eye Drop products.
The recall was initiated July 14 by manufacturer Rohto-Mentholatum (Vietnam) Co., Ltd. The recall covers products distributed nationwide by The Mentholatum Company.
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The FDA assigned the action a Class II classification, meaning the products may cause temporary or reversible adverse health consequences, or the probability of serious harm is considered remote.
Why the products were recalled
The reason cited across all eight recalled products is a “lack of assurance of sterility.” Eye drop products are required to be sterile because they are applied directly to the eye.
Which products are affected
Eight distinct Rohto Cooling Eye Drop products are included in the recall, spanning multiple formulations and lot numbers.
Click here to see the list.
What consumers should do
Anyone who has purchased a Rohto Cooling Eye Drop product should check the UPC number and lot number on their package against the FDA’s recall list. Expiration dates on affected lots range from July 2026 through February 2029, meaning many products currently in homes and on store shelves may be impacted.
Consumers should stop using any recalled product immediately. The FDA recommends contacting the recalling firm or a healthcare provider with any questions. Those who have experienced adverse effects after using these products are encouraged to report them through the FDA’s MedWatch program at fda.gov/safety/medwatch or by calling 1-800-FDA-1088.