The voluntary recall<\/a> was issued by Vietnam-based Rohto-Mentholatum and includes eye drops marketed to relieve redness, dryness and eye strain.<\/p>\n According to the FDA, the recall affects 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide.<\/p>\n The FDA said the products were recalled because of a “lack of assurance of sterility,” meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms.<\/p>\n MILLIONS OF PRESCRIPTION EYE DROPS RECALLED NATIONWIDE OVER CONTAMINATION CONCERNS<\/a><\/p>\n Rohto Cooling Eye Drops are being recalled nationwide after the FDA cited concerns about the products’ sterility. (Getty Images \/ Getty Images)<\/p>\n Federal regulators classified the action as a Class II recall, meaning use of the products could cause temporary or medically reversible health effects, but serious adverse health consequences are unlikely.<\/p>\n The recall covers eight Rohto Cooling Eye Drops products \u2014 including ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief \u2014 in single and twin-pack configurations.<\/p>\n Affected products carry expiration dates ranging from July 2025 through February 2029. Consumers should compare the lot number and expiration date on their packaging with the manufacturer’s<\/a> recall notice or the FDA’s website to determine whether their product is included.<\/p>\n MORE THAN 120K REFRIGERATORS RECALLED AFTER 34 FIRES AND ONE REPORTED DEATH<\/a><\/p>\n The FDA said millions of bottles of Rohto eye drops are included in a nationwide recall over sterility concerns. (Getty Images \/ Getty Images)<\/p>\n The eye drops were manufactured by Rohto-Mentholatum in Vietnam and distributed by The Mentholatum Company, based in Orchard Park, New York.<\/p>\n Consumers whose products are included in the recall should stop using them immediately and either dispose of them or return them to the place of purchase for a full refund.<\/p>\n Rohto eye drops sold in the United States are being recalled after the FDA reported a lack of assurance of sterility. (Getty Images \/ Getty Images)<\/p>\n The recall comes after the FDA recently classified the recall of more than 2.5 million bottles of a prescription steroid eye medication as a Class II action because of concerns about foreign material found in certain lots.<\/p>\n![](\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/08\/man-putting-in-eyedrops-recall.jpg\"\/)
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