Millions of Popular Eye Drop Cartons Recalled Nationwide Over Safety Concerns
Washington, Wednesday, 29 July 2026.
The FDA issued a Class II recall for nearly 12 million cartons of Rohto Cooling Eye Drops after discovering potential sterility issues that risk user safety.
FDA Initiates Major Recall Over Sterility Concerns
The U.S. Food and Drug Administration has mandated a nationwide recall affecting nearly 12 million cartons of Rohto Cooling Eye Drops due to significant sterility concerns [1][3]. Announced publicly in late July 2026, this regulatory action targets specific lot numbers across eight product varieties distributed throughout the United States [1][3]. The recall was voluntarily initiated by the distributor on July 14, 2026, and subsequently classified by the FDA on July 23, 2026 [3][4]. This development highlights ongoing vigilance within the pharmaceutical supply chain, particularly for over-the-counter ophthalmic products where sterility is paramount for user safety [1][3].
Health Implications and Regulatory Classification
The FDA has categorized this event as a Class II recall, indicating that while the use of these products may cause temporary or reversible health effects, the likelihood of serious adverse consequences remains low [1][3]. Despite the scale of the recall, no illnesses have been reported in connection with the affected lots as of July 29, 2026 [1][4]. The core issue stems from a lack of assurance of sterility, prompting regulators to advise immediate cessation of use for any products matching the recalled lot numbers [2][3]. Consumers are urged to verify their inventory against the provided list to mitigate potential risks associated with non-sterile ophthalmic solutions [2][4].
Scope of the Recall and Affected Products
The recall encompasses a wide range of Rohto Cooling Eye Drops varieties, including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief [1][3]. Specific carton counts provided in enforcement reports detail the magnitude of the affected inventory across these product lines [1]. For instance, the Max Strength variety accounts for over 6 million single cartons and approximately 499,000 twin pack cartons, representing a significant portion of the total recalled volume [1]. When aggregating the specific carton counts listed for all affected varieties—such as 1,033,266 for All-In-One and 2,910,148 for Cool Relief—the total aligns with the reported figure of nearly 12 million cartons 11.961 million [1].
Supply Chain and Distribution Details
Distribution of the recalled products is managed by The Mentholatum Company, headquartered in Orchard Park, New York [1][3]. Manufacturing operations for the affected eye drops were conducted by Rohto-Mentholatum in Vietnam, reflecting the global nature of the pharmaceutical supply chain [1][3]. The products were sold both individually and in two-pack sets at various retail locations across the country [1]. This geographic dispersion necessitates a broad consumer awareness campaign to ensure all affected units are identified and removed from use [2][4].
Consumer Guidance and Timeline
Consumers possessing Rohto Cooling Eye Drops are advised to check the lot numbers and expiration dates printed on their packaging immediately [1][3]. If the product matches the recalled lots, the FDA instructs users to stop using the drops and either dispose of them or return them to the place of purchase [1][4]. The enforcement database remains accessible for users to verify specific lot codes associated with the recall [2][3]. As of today, July 29, 2026, the recall remains active, and public health officials emphasize compliance to prevent potential eye infections or complications [3][4].