The recalled product is marketed as a treatment for redness and dryness linked to prolonged screen time. The recall concerns bottles distributed across the United States, with federal regulators warning that the lack of confirmed sterility could create a risk of adverse health effects.
According to an enforcement report issued by the FDA, the recall was launched because of a “lack of assurance of sterility.” The agency said the manufacturer could not confirm that the eye drops were produced in conditions designed to prevent contamination.
The affected product is sold in 0.4 fl oz (13 mL) bottles and contains hypromellose 0.35% and tetrahydrozoline HCl 0.05%. The eye drops are distributed by The Mentholatum Company of Orchard Park, New York, and manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd.
Recall Affects Specific Rohto Eye Drop Lots Nationwide
A total of 65,219 cartons of Rohto Cooling Eye Drops Digi Eye are included in the recall. The affected lots are 4B1V, 4B1VA, and 4J1V, with expiration dates of January 2027 and September 2027.
According to the FDA, the recall has been classified as a Class II recall. This classification means that use of the product could cause “temporary or medically reversible adverse health consequences.”
The voluntary recall was initiated by Rohto-Mentholatum (Vietnam) Co., Ltd. on July 14 and received its official FDA classification on July 23. The products were distributed nationwide in the United States.
On its website, the company describes the product as designed for people experiencing discomfort linked to digital device use, stating that the eye drops are “specially formulated to deliver instant cooling and long-lasting soothing relief.”
FDA Reports Another Over-The-Counter Medication Recall
The eye drop recall comes shortly after another medication recall involving a widely used over-the-counter product. The FDA announced the voluntary recall of four lots of generic cetirizine hydrochloride tablets, commonly sold as over-the-counter versions of Zyrtec.
According to the FDA, the tablets were recalled after they were found to have potentially been cross-contaminated with ranitidine, a stomach acid medication previously sold under the brand name Zantac.
Ranitidine was removed from the U.S. market in 2020 following contamination concerns involving a probable human carcinogen. A reformulated version returned in 2025.
Federal regulators warned that the contamination issue could be particularly dangerous for people allergic to ranitidine. Possible reactions include anaphylaxis, a rapid and potentially life-threatening allergic reaction.
Other Consumer Product Recalls Raise Safety Concerns
The Rohto eye drop recall also follows a separate nationwide warning involving vitamin and supplement products earlier this year.
More than 356,000 iron-containing vitamins and supplements made by Vitaquest were recalled after the products were found to have been packaged without child-resistant caps.
According to the U.S. Consumer Product Safety Commission, the packaging issue creates “a risk of serious injury or death from poisoning if the contents are swallowed by young children.”
The recent recalls involve different types of consumer products, but each action was linked to concerns identified by federal regulators regarding product safety and potential risks for users.
