Major Eye Drop Recall Affects Over 12 Million Bottles, Per FDA
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Over 12 Million Bottles of ‘Cooling’ Eye Drops Recalled Nationwide

The U.S. Food and Drug Administration says that the over-the-counter Rohto eye drops did not meet safety standards.
Over 12 Million Bottles of ‘Cooling’ Eye Drops Recalled Nationwide
Everyday Health

Eight different types of Rohto Cooling Eye Drops sold over the counter have been recalled nationwide because of concerns that they may not be sterile and could potentially become contaminated with germs that can cause eye infections.

A report from the U.S. Food and Drug Administration (FDA) described this as a “class 2” recall, which indicates that the products in question “may cause temporary or medically reversible adverse health consequences,” or that the “probability of serious adverse health consequences is remote.

Rohto-Mentholatum manufactures the eye drops in Vietnam. They are distributed by the Mentholatum Company across the United States.

You can find a full list of the affected eye drops in the FDA enforcement report.

If you have the eye drops, don’t use them; discard them.

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Resources
  1. Recalls Background and Definition. U.S. Food and Drug Administration. March 20, 2026.

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