FDA recalls nearly 12 million bottles of Rohto eye drops due to sterility concerns

Nearly 12 million bottles of Rohto eye drops have been recalled due to concerns regarding their sterility, as reported in a recent enforcement notice from a media source. This voluntary recall was initiated by Rohto-Mentholatum, a company based in Vietnam, and pertains to eye drops designed to alleviate redness, dryness, and eye strain.

The U.S. Food and Drug Administration (FDA) indicated that the recall includes approximately 11,960,623 cartons of Rohto Cooling Eye Drops that have been distributed across various retail outlets nationwide. The primary reason for the recall is a “lack of assurance of sterility,” which raises concerns about the potential presence of harmful microorganisms in the eye drops.

Federal regulators have classified the action as a Class II recall. This classification suggests that, while the use of the affected products could lead to temporary or medically reversible health effects, the likelihood of serious adverse health outcomes is considered low. The recall covers eight different products under the Rohto Cooling Eye Drops line, which includes formulations like ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief. These products are sold in both single and twin-pack configurations.

For consumers who have purchased these eye drops, the FDA advises that they check the lot numbers and expiration dates against the manufacturer’s recall notice or the FDA website to determine if their products are part of the affected lot, with expiration dates ranging from July 2025 to February 2029.

Rohto-Mentholatum, the manufacturer of the recalled eye drops, operates in partnership with The Mentholatum Company, a distributor headquartered in Orchard Park, New York. Consumers are advised to discontinue use of the recalled products immediately. They may return the items to the retailer for a full refund or dispose of them safely.

This incident follows a series of other recalls initiated by the FDA, including a recently reported Class II recall involving more than 2.5 million bottles of a prescription steroid eye medication. These recalls highlight ongoing concerns regarding product safety within the pharmaceutical and healthcare sectors.

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