Rohto Cooling Eye Drops Pulled Nationwide in Class II Recall

More than 12 million bottles of Rohto Cooling Eye Drops are affected by a nationwide recall involving specific products, lots and expiration dates.

Nearly 12 million cartons of Rohto Cooling Eye Drops have been recalled across the United States because the manufacturer could not provide adequate assurance that the products were sterile.
The recall covers 11,960,623 cartons, representing approximately 12,460,649 individual bottles after accounting for products sold in two-packs.

Rohto-Mentholatum (Vietnam) Co., Ltd. initiated the voluntary recall on July 14, 2026. The affected products were distributed nationwide by The Mentholatum Company of Orchard Park, New York.

The U.S. Food and Drug Administration classified the action as a Class II recall on July 23. The agency’s enforcement record lists “lack of assurance of sterility” as the reason for the recall.(1^✔ ✔Trusted Source
More than 11 million cartons of eye drops recalled nationwide over concerns about sterility

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Class II Recall Indicates a Lower but Meaningful Risk

An FDA Class II recall means that using or being exposed to the affected product may cause temporary or medically reversible health effects. It may also mean that the probability of serious harm is considered remote.

The classification does not confirm that the eye drops are contaminated. Instead, it indicates that the manufacturer cannot adequately guarantee that affected products meet the sterility standards required for medicines applied directly to the eye.

Eight Rohto Product Configurations Are Affected

The recall covers specific lots of the following products:

• Rohto Cooling Eye Drops All-in-One — 1,033,266 cartons
• Rohto Cooling Eye Drops Max Strength — 6,076,306 cartons
• Rohto Cooling Eye Drops Max Strength Twin Pack — 499,673 cartons
• Rohto Cooling Eye Drops Optic Glow — 1,278,457 cartons
• Rohto Cooling Eye Drops Digi Eye — 65,219 cartons
• Rohto Cooling Eye Drops Dry Aid — 97,201 cartons
• Rohto Cooling Eye Drops Dry Aid Twin Pack — 353 cartons
• Rohto Cooling Eye Drops Cool Relief — 2,910,148 cartons

Not every bottle sold under these names is included. The recall applies only to specified UPCs, lot numbers and expiration dates.(1^✔ ✔Trusted Source
More than 11 million cartons of eye drops recalled nationwide over concerns about sterility

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Affected expiration dates range from July 2026 through February 2029. Some listed Optic Glow lots carry earlier expiration dates, indicating that consumers should rely on the complete FDA record rather than checking the expiration year alone.(1^✔ ✔Trusted Source
More than 11 million cartons of eye drops recalled nationwide over concerns about sterility

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Uses of the Recalled Rohto Eye Drops

The recalled Rohto products are over-the-counter drops used for temporary relief of redness, dryness, itching, burning, grittiness and irritation.These products do not treat infections or serious eye diseases.

Sterility Is Essential for Eye-Drop Safety

Eye drops must be sterile because they are administered directly onto the eye’s surface.

The FDA explains that ophthalmic medicines pose a heightened risk because they bypass some of the body’s natural defences. Loss of sterility can allow bacteria, fungi or other microorganisms to enter the eye, potentially causing irritation or infection.

Previous contaminated eye-drop incidents have been linked to serious complications, although the Class II classification indicates that severe outcomes from the current recall are considered unlikely.

The FDA advises consumers to stop using eye drops and contact a healthcare professional if they develop eye discharge, pain, discomfort or changes in vision.

Consumers Should Check the UPC and Lot Number

People who have Rohto Cooling Eye Drops at home should compare the product name, UPC, lot number and expiration date printed on the packaging with the FDA recall record.

Consumers with an affected product should:

• Stop using the recalled eye drops
• Return the product to the place of purchase or dispose of it safely
• Avoid continuing use simply because the bottle appears normal
• Contact a healthcare professional if eye symptoms develop
• Report adverse reactions or product-quality concerns through the FDA’s MedWatch programme

Symptoms such as eye pain, discharge, persistent redness, discomfort or changes in vision should receive prompt medical attention.

Reference:

1. More than 11 million cartons of eye drops recalled nationwide over concerns about sterility- (https://www.abc10.com/article/news/nation-world/rohto-eye-drops-recall-full-list/507-761f74a4-d148-4673-a09b-5a6ed9d8239d)

Source-Medindia