More Than 12 Million Rohto 'Cooling' Eye Drop Bottles Recalled Nationwide Over Sterility Concerns

More than 12 million bottles of Rohto Cooling Eye Drops sold over the counter in the United States have been recalled after the manufacturer could not fully assure product sterility.

The U.S. Food and Drug Administration (FDA) says the recall includes eight different Rohto Cooling Eye Drop variants and has been classified as a Class 2 recall. A Class 2 designation means the products "may cause temporary or medically reversible adverse health consequences," while the likelihood of serious long-term harm is considered remote.

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What You Need To Know

Rohto-Mentholatum manufactures the eye drops in Vietnam; the Mentholatum Company distributes them throughout the U.S. The FDA enforcement report contains the full list of affected product names, SKUs, and lot numbers — consumers should consult that report to determine whether their bottle is included.

Safety Recommendations

• Do not use any bottle you believe may be part of the recall.
• Safely dispose of recalled bottles or follow return instructions from the retailer or manufacturer.
• If you have used a recalled product and develop symptoms such as redness, eye pain, discharge, or changes in vision, seek medical attention promptly.

Contaminated eye drops can introduce bacteria or other germs into the eye and may cause infections. For the most accurate and up-to-date information, review the FDA enforcement report on this recall and follow any guidance from your healthcare provider, the retailer where you purchased the product, or the manufacturer.

Sources: U.S. Food and Drug Administration recall/enforcement report; manufacturer recall notice.