Rohto Recalls Nearly 12 Million Eye Drops Due to Sterility Concerns
The FDA has flagged a voluntary recall of Rohto Cooling Eye Drops, citing a lack of assurance that the products are sterile.
Nearly 12 million bottles of Rohto eye drops have been recalled nationwide due to concerns that the products may not be sterile, according to a Food and Drug Administration (FDA) enforcement report. The voluntary recall was initiated by Rohto-Mentholatum, a Vietnam-based company, and affects eye drops marketed for the relief of redness, dryness, and eye strain.
The recall encompasses 11,960,623 cartons of Rohto Cooling Eye Drops distributed across the United States. The FDA stated that the recall is due to a "lack of assurance of sterility," meaning the products may not be free from potentially harmful microorganisms. Federal regulators have classified this action as a Class II recall, indicating that while the use of the products could lead to temporary or medically reversible health effects, serious adverse health consequences are unlikely.
The affected products include eight varieties of Rohto Cooling Eye Drops, such as ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, available in both single and twin-pack configurations. These products have expiration dates ranging from July 2025 through February 2029. Consumers can verify if their product is included in the recall by checking the lot number and expiration date on the packaging against the manufacturer's recall notice or the FDA's website.
The eye drops were manufactured in Vietnam by Rohto-Mentholatum and distributed by The Mentholatum Company, located in Orchard Park, New York. Consumers with affected products are advised to stop using them immediately and either dispose of them or return them to the point of purchase for a full refund.
This recall follows other recent actions concerning eye medications. The FDA recently classified a recall of over 2.5 million bottles of a prescription steroid eye medication as a Class II action due to concerns about foreign material found in certain lots. Separately, last month, the FDA announced the recall of certain generic cetirizine hydrochloride tablets, commonly sold as generic Zyrtec, over concerns of potential cross-contamination with another medication that could lead to life-threatening reactions.