FDA Issues Recall for 12 Million Bottles of Rohto Eye Drops

WHO:

Fox Business - The recall was issued by Vietnam-based Rohto-Mentholatum and distributed by The Mentholatum Company, based in Orchard Park, New York.

WHAT:

Fox Business - Nearly 12 million bottles of Rohto eye drops have been recalled due to concerns they may not be sterile.

Fox Business - The recall affects 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide.

Fox Business - The recall covers eight Rohto Cooling Eye Drops products, including ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, in single and twin-pack configurations.

NY Post - The Class II recall covers products with expiration dates from July 2025 through February 2029.

WHERE:

Fox Business - The eye drops were distributed nationwide across the United States.

WHEN:

Fox Business - Affected products carry expiration dates ranging from July 2025 through February 2029.

WHY:

Fox Business - The FDA stated the recall was due to a "lack of assurance of sterility," meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms.

Fox Business - The recall was classified as a Class II action, indicating that use of the products could cause temporary or medically reversible health effects, but serious adverse health consequences are unlikely.

HOW:

Fox Business - Consumers are advised to compare the lot number and expiration date on their packaging with the manufacturer's recall notice or the FDA's website to determine if their product is included.

Fox Business - 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.

(UPDATED August 1, 2026 16:21 UTC)

Nearly 12 million bottles of Rohto Cooling Eye Drops have been recalled due to concerns over sterility, affecting almost 12 million cartons distributed nationwide across the United States. This Class II recall includes eight different products, with expiration dates ranging from July 2025 through February 2029, and the FDA has indicated that the lack of assurance of sterility could lead to temporary health effects. Consumers are urged to check their packaging against the recall notice and stop using any affected products, returning them for a full refund or disposing of them immediately.