FDA orders recall of nearly 12 million Rohto eye drop bottles over sterility doubts
The FDA has classified a voluntary recall of almost 12 million Rohto Cooling Eye Drops as a Class II action because sterility cannot be guaranteed.
A Food and Drug Administration enforcement report announced a Class II recall of nearly 12 million bottles of Rohto Cooling Eye Drops due to uncertainty about their sterility. The voluntary recall was initiated by Vietnam-based Rohto-Mentholatum and includes eight formulations such as ALL-IN-ONE, Max Strength, and Cool Relief, sold in single and twin packs. Distributed nationwide by The Mentholatum Company of Orchard Park, New York, the affected cartons bear expiration dates ranging from July 2025 through February 2029.
A Class II designation means use may lead to temporary or medically reversible eye effects, though serious health outcomes are unlikely. Consumers should compare their product’s lot number and expiry date with the FDA’s recall list and either discard the drops or return them for a full refund. The action follows recent FDA Class II recalls of other eye medications and generic antihistamine tablets over contamination concerns.
Why it matters
Consumers using the recalled eye drops could experience eye irritation, so checking and removing the product prevents health risks.
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