More than 11 million packages of a popular over-the-counter eye drop medication are being recalled due to undisclosed sterility issues, according to a recent notice published by the Food and Drug Administration.
Vietnam-based Rohto-Mentholatum Co., Ltd. is recalling several lots of Rohto Cooling Eye Drops in different strengths that were sold across the United States, said an FDA enforcement report.
The recall was initiated on July 14 by the company and was classified by the FDA on July 23.
According to the notice, the reason for the recall was due to a “lack of assurance of sterility,” although further details were not disclosed. A separate guideline published on the FDA’s website indicates that companies should try to “remove contaminants or impurities such as particulates, endotoxins, and degradants.”
The FDA classified the recall as Class II, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
In all, the recall enforcement report lists 11,960,623 cartons of eye drops, which contain 12,460,649 bottles, as being under recall.
In 2023, the FDA warned consumers to stop using more than two dozen over-the-counter eye drop products because they may cause an eye infection that could lead to vision loss. The drops were marketed under CVS Health, Leader, Rite Aid, Target, Walmart, Velocity Pharma, and Rugby.
And in February of that year, the Centers for Disease Control and Prevention confirmed an outbreak of Pseudomonas aeruginosa, a type of drug-resistant bacteria, linked to the contamination of other brands of eyedrops and artificial tears.
List of Impacted Products
Several lots of the following Rohto Cooling Eye Drops products were included in the recall, according to the notice:
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Rohto Cooling Eye Drops All-In-One; 1,033,266 cartons;
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Rohto Cooling Eye Drops Max Strength; 6,076,306 cartons of single variety and 499,673 cartons of twin pack;
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Rohto Cooling Eye Drops Optic Glow; 1,278,457 cartons;
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Rohto Cooling Eye Drops Digi Eye; 65,219 cartons;
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Rohto Cooling Eye Drops Dry Aid; 97,201 cartons of single variety and 353 cartons of twin pack;
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Rohto Cooling Eye Drops Cool Relief; 2,910,148 cartons;
The products have expiration dates ranging between July 2026 and February 2029, it said. Other details about the recall were not provided in the notice.