Rohto Recalls

FDA Recalls Nearly 12 Million Rohto Cooling Eye Drops: What Patients Need to Know

If you use over the counter eye drops for redness, dryness, or tired eyes, it is important to check your medicine cabinet. The U.S. Food and Drug Administration (FDA) has announced a nationwide recall affecting nearly 12 million bottles of certain Rohto Cooling Eye Drop products because the manufacturer could not verify that the products met sterility requirements during production.

Although the recall has been classified as a Class II recall, meaning the chance of serious health problems is considered low, using eye drops that may not be sterile could increase the risk of eye irritation or infection.
 

Why Were These Eye Drops Recalled?

Eye drops must be sterile because they are placed directly into the eye. During routine quality reviews, concerns were identified regarding the manufacturing process, making it impossible to confirm that the affected products were completely sterile.

This does not necessarily mean the eye drops are contaminated. Rather, the manufacturer could not provide sufficient evidence that every bottle met the required sterility standards.
 

Which Products Are Included?

The recall includes certain lot numbers of several Rohto Cooling Eye Drop products, including:

• Rohto Cooling Eye Drops All In One

• Rohto Cooling Eye Drops Max Strength

• Rohto Cooling Eye Drops Optic Glow

• Rohto Cooling Eye Drops Digi Eye

• Rohto Cooling Eye Drops Dry Aid

• Rohto Cooling Eye Drops Cool Relief
   

Some twin pack versions are also included. Not every bottle of these products has been recalled, so patients should check the lot number and expiration date on the package to determine if their product is affected.
 

What Should You Do If You Have These Eye Drops?

If you own one of the recalled products:

• Stop using the eye drops until you determine whether your bottle is part of the recall.

• Check the lot number and expiration date against the FDA recall notice.

• Return the product to the place of purchase or dispose of it according to the manufacturer's instructions.

• Contact your eye doctor if you experience any symptoms after using the product.
   

Symptoms to Watch For

While most people will not experience serious problems, you should seek prompt eye care if you develop:

• Increasing eye redness

• Eye pain

• Light sensitivity

• Blurred vision

• Eye discharge

• Swelling around the eye

• Sudden changes in vision
   

Eye infections can become serious if left untreated, so it is important to have any concerning symptoms evaluated as soon as possible.
 

Tips for Safe Eye Drop Use

To reduce your risk of eye infections:

• Wash your hands before using eye drops.

• Avoid touching the bottle tip to your eye, eyelashes, or fingers.

• Never share eye drops with another person.

• Replace expired eye drops.

• Store eye drops according to the instructions on the label.
   

If you regularly use artificial tears or redness relieving drops, your optometrist can recommend safe alternatives if your current product is affected by the recall.
 

When Should You Schedule an Eye Exam?

If you have used one of the recalled eye drops and notice persistent redness, irritation, pain, blurred vision, or any change in your eyesight, schedule an eye examination promptly. Early diagnosis and treatment can help prevent more serious complications.

At Eyes & Optics, we are committed to helping our patients protect their vision and stay informed about important eye health updates. If you have questions about this recall or need recommendations for safe over the counter eye drops, our team is here to help.
 

Sources

U.S. Food and Drug Administration. Class II Recall: Rohto Cooling Eye Drop Products. 2026.

Eyes On Eyecare. FDA Recalls Nearly 12 Million Rohto Cooling Eye Drop Products. July 30, 2026.

The Mentholatum Company. Product Recall Information. 2026.