Full Breakdown
FDA Issues Nationwide Recall of Millions of Rohto Cooling Eye Drops
7/31/2026, 11:32:29 AM
Recall Overview
On July 14, 2026, Rohto-Mentholatum (Vietnam) Co., Ltd. voluntarily initiated a recall of eight Rohto Cooling Eye Drop products distributed across the United States by The Mentholatum Company of New York. The Food and Drug Administration (FDA) classified the action as a Class II recall on July 23, indicating that the products may cause temporary or reversible adverse health effects but are unlikely to result in serious harm.
Scope and Products Affected
The FDA’s enforcement report lists 11,960,623 cartons (equating to 12,460,649 bottles) that lack “assurance of sterility.” The recall encompasses eight distinct formulations marketed under the Rohto Cooling Eye Drops brand, including All-in-One, Max Strength, Optic Glow, Digi Eye, Dry Aid, Cool Relief, and two-pack variations. Expiration dates on the affected lots range from July 2026 through February 2029, meaning many units remain on store shelves and in households.
Reason for Recall and FDA Classification
Eye drops must be sterile because they are applied directly to the eye. The FDA determined that the recalled batches could have lost sterility, raising the risk of microbial contamination and infection. Under the Class II designation, the agency notes that the probability of serious health consequences is considered remote, though temporary irritation or infection remains possible.
Guidance for Consumers
The FDA advises anyone who purchased a recalled Rohto Cooling Eye Drop product to:
- Verify the UPC and lot number on the package against the FDA’s online recall list.
- Stop using the product immediately.
- Return the product to the place of purchase, contact the recalling firm, or consult a healthcare provider for further instructions.
- Report any adverse effects through the FDA’s MedWatch program (fda.gov/safety/medwatch) or by calling 1-800-FDA-1088.
Manufacturer and FDA Response
Rohto-Mentholatum, which manufactures the eye drops in Vietnam and distributes them from New York, initiated the recall on July 14, 2026 after the FDA identified sterility concerns. The agency’s classification and public notice were posted on its enforcement report website, providing lot-specific details for consumers and retailers. No serious health incidents have been reported, and the FDA emphasizes that the recall is precautionary to protect public health.
