Nearly 12 million bottles of Rohto Cooling Eye Drops recalled across the United States after concerns that some products may not be sterile, according to an enforcement report issued by the US Food and Drug Administration (FDA).
The voluntary recall covers 11,960,623 cartons of eye drops manufactured by Vietnam-based Rohto-Mentholatum and distributed nationwide by The Mentholatum Company, based in Orchard Park, New York, reported Fox Business. The products are commonly used to relieve eye redness, dryness and eye strain.
According to the FDA, the recall was issued because of a “lack of assurance of sterility.” This means the manufacturer cannot confirm that the affected eye drops are completely free from potentially harmful microorganisms.
The FDA has classified the action as a Class II recall, which means that use of the products may cause temporary or medically reversible health problems, although the risk of serious health consequences is considered low.
Which eye drop products are included in the recall?
The recall applies to eight Rohto Cooling Eye Drops products sold in both single-pack and twin-pack versions. The affected range includes Rohto ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief products, reported Fox Business.
According to the FDA, the recalled products carry expiration dates ranging from July 2025 through February 2029. Consumers have been advised to check both the lot number and expiration date on the packaging and compare them with the manufacturer’s recall notice or the FDA’s recall information to determine whether their eye drops are affected.
The products were manufactured by Rohto-Mentholatum in Vietnam before being distributed in the United States by The Mentholatum Company.
What should consumers do?
The FDA advises consumers to stop using any recalled eye drops immediately if their product matches the affected lot numbers. Customers can either safely dispose of the products or return them to the place of purchase to receive a full refund.
Because eye drops come into direct contact with the eyes, sterility plays a critical role in product safety. If a product is contaminated with microorganisms, it could increase the risk of eye irritation or infection.
The latest recall follows several other FDA enforcement actions involving eye care and pharmaceutical products in recent months.
Earlier, the FDA classified the recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension USP, 1%, as a Class II action after foreign material was found in certain lots, reported Fox Business. According to the FDA, Lupin Pharmaceuticals voluntarily recalled 2,530,182 bottles of the prescription steroid eye medication after identifying the presence of a foreign substance.
The FDA also recently announced the recall of certain lots of generic cetirizine hydrochloride tablets, widely sold as generic versions of Zyrtec. The agency said the products could have been cross-contaminated with another medication that may trigger potentially life-threatening reactions in some users.