Rohto-Mentholatum initiated a voluntary recall of eight Cooling Eye Drop products on July 14, covering more than 12 million bottles distributed nationwide, according to the Food and Drug Administration.
The recall encompasses 11,960,623 cartons containing 12,460,649 bottles, the FDA said. All eight products share the same stated basis for the recall — a "lack of assurance of sterility" — which indicates that their sterile integrity may have been compromised, potentially exposing users to germ contamination or infection. Eye drops are required to be sterile because they are applied directly to the eye.
Under a Class II designation, the FDA considers the risk of serious harm to be remote, with any adverse health effects expected to be temporary or reversible, according to News4Jax.
The products are manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. and distributed in the United States by The Mentholatum Company, which is based in New York, according to USA Today. The medication was sold over-the-counter at retailers nationwide, the FDA said.
Affected lots carry expiration dates stretching from July 2026 to February 2029, which means bottles already purchased or still sitting on retailer shelves could fall under the recall, according to News4Jax. Consumers should check the UPC number and lot number on their package against the FDA's recall list.
Anyone who has purchased a recalled product should stop using it immediately. Returning the product to the store where it was bought is one option worth exploring, and consumers should call their local retailer directly to find out what is available to them, according to USA Today. Anyone who has had a negative reaction after using the drops can submit a report to the FDA's MedWatch safety program at fda.gov/safety/medwatch or by dialing 1-800-FDA-1088.
This recall is part of a broader pattern of eye drop sterility concerns in recent months, including a recall of more than 3.1 million store-brand eye drop bottles from KC Pharmaceuticals — sold under CVS, Walgreens $WBA, Kroger, and other retailer labels — also citing a lack of assurance of sterility, as well as a separate recall of more than 2.5 million bottles of Lupin Pharmaceuticals prescription steroid eye drops after the FDA found a potential foreign substance in the product. Both of those recalls were also classified as Class II.