More than 12 million bottles of Rohto-brand eye drops are being recalled nationwide due to a potential lack of sterility, raising concerns about possible harm to vision. The U.S. Food and Drug Administration (FDA) has designated this a Class II recall, signifying a temporary and reversible risk if the affected products are used.
The manufacturer, Rohto-Mentholatum, distributed the recalled eye drops in the U.S. by The Mentholatum Company. The specific products include Rohto Cooling Eye Drops ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief. These medications are intended to alleviate eye redness, inflammation, and other issues.
The recall encompasses 12 million cartons, though the exact number of bottles per carton was not specified. The affected eye drops were sold nationwide in 0.4 fl oz bottles with various lid colors including blue, red, green, black, and a pink bottle with a black lid. These products have best-before dates extending up to August 2028. A comprehensive list of recalled lot numbers is available on the FDA website.
While no illnesses or injuries have been reported in connection with this specific recall, the FDA's classification suggests that use of these drops could pose a risk to eye health. In previous instances involving contaminated eye drops, consumers have been advised to discontinue use immediately and return the products for a refund.
This recall follows a significant incident in 2023 where eye drops manufactured in India were recalled due to contamination with a dangerous bacteria. That recall was linked to 81 patient illnesses, 18 cases of permanent blindness, and four deaths. In April of the current year, over three million eye drops from California-based K.C. Pharmaceuticals were also recalled for a similar lack of assurance of sterility. Those recalled drops were sold at major retailers including CVS, Walgreens, Kroger, and H-E-B.