Rohto Voluntarily Recalls 12.46 Million Cooling Eye Drop Bottles Over Sterility Concerns

Rohto-Mentholatum announced a voluntary recall on July 14 covering eight Cooling Eye Drop products after the U.S. Food and Drug Administration flagged potential sterility issues affecting more than 12 million bottles nationwide.

Details of the Recall

The FDA says the recall includes 11,960,623 cartons containing 12,460,649 bottles. All eight products were recalled for the same reason: a stated “lack of assurance of sterility,” which means the sterile integrity of the product may have been compromised and could expose users to contamination or infection. Because eye drops are applied directly to the eye, they must be sterile.

Manufacturing and Distribution

The products were manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. and distributed in the United States by The Mentholatum Company, based in New York. The eye drops were sold over the counter at retailers nationwide.

Expiration Dates and Classification

Affected lots carry expiration dates from July 2026 through February 2029, so bottles already purchased or still on store shelves may be included in the recall. The FDA has classified the action as a Class II recall, indicating that serious harm is considered remote and any adverse effects are expected to be temporary or reversible.

What Consumers Should Do

• Stop using any product you believe is part of the recall.
• Check the UPC and lot number on your package against the FDA’s published recall list before discarding or returning the item.
• Return or contact the retailer where you bought the product to learn about return, refund, or exchange options.
• Report any adverse reactions to the FDA’s MedWatch program at fda.gov/safety/medwatch or by calling 1-800-FDA-1088.

Context

This recall is part of a recent series of eye-drop safety actions. In the same timeframe, more than 3.1 million store-brand eye-drop bottles made by KC Pharmaceuticals were recalled for similar sterility concerns, and over 2.5 million bottles of Lupin Pharmaceuticals’ prescription steroid eye drops were recalled after a potential foreign substance was identified. Both of those incidents were also classified as Class II recalls.

Bottom line: If you own the affected Rohto Cooling Eye Drops, stop use immediately, compare UPC/lot information with the FDA recall list, and contact your retailer or the FDA if you have health concerns.