Rohto-Mentholatum Recalls 11.96 Million Eye Drops Over Sterility Risk
Updated
Updated · NBC DFW · Jul 31
Rohto-Mentholatum Recalls 11.96 Million Eye Drops Over Sterility Risk
3 articles · Updated · NBC DFW · Jul 31
Summary
11,960,623 cartons of Rohto Cooling Eye Drops were pulled nationwide in a voluntary recall after FDA flagged a manufacturing-related lack of sterility assurance.
Class II status means the affected drops could cause temporary or reversible health effects because they cannot be guaranteed free of potentially harmful microbes.
Eight varieties are covered — including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief — in single and twin packs with expiration dates from July 2026 to February 2029.
FDA said consumers should stop using recalled lots immediately and either discard the products or return them to the place of purchase for a full refund.
The drops were made by Rohto-Mentholatum in Vietnam and distributed in the U.S. by The Mentholatum Company of Orchard Park, New York.