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Rohto-Mentholatum Recalls Over 12 Million Bottles of Cooling Eye Drops Due to Sterility Concerns

Rohto-Mentholatum has issued a voluntary nationwide recall of approximately 11,960,623 cartons of Rohto Cooling Eye Drops. The recall was initiated because the products lacked assurance of sterility, meaning the eye drops could potentially be contaminated by harmful microorganisms. The Food and Drug Administration (FDA) classified the action as a Class II recall, indicating that while the use of the products may cause temporary or reversible health effects, serious adverse consequences are unlikely. The affected products include eight different varieties of Rohto Cooling Eye Drops, such as All-in-One, Max Strength, and Optic Glow, sold in both single and twin-pack configurations. The eye drops were manufactured in Vietnam and distributed by The Mentholatum Company in New York. Consumers are advised to stop using the recalled bottles immediately and should either dispose of them or return them to the place of purchase for a full refund. For further information, consumers can contact the FDA at 1-888-INFO-FDA.

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