Over 12 Million Rohto Eye Drops Recalled: What You Need to Know

Updated July 30, 2026, 3:58 p.m. ET

What Happened?

The Food and Drug Administration (FDA) has announced a nationwide recall of more than 12 million bottles of Rohto-brand over-the-counter eye drops. The recall was started by the manufacturer, Rohto-Mentholatum, on July 14, 2026.

Key Fact: The eye drops are made in Vietnam and distributed in the U.S. by the Mentholatum Company, based in New York.

Why Were They Recalled?

The FDA classifies this as a Class II recall. Here’s what that means in simple terms:

• Class II = The product might cause temporary health issues (like irritation or infection), but it is unlikely to cause serious or permanent harm.
• The specific problem: "Lack of assurance of sterility."
  Think of sterility like a "germ-free guarantee." The bottles may have lost that guarantee, meaning bacteria or other germs could be inside. Using contaminated eye drops can lead to eye infections.

Important: Even if the drops look clear and smell fine, they could still be unsafe. Do not use them.

Which Products Are Affected?

Eight different types of Rohto eye drops are included in the recall. They were sold over-the-counter (without a prescription) at stores nationwide.

The FDA enforcement report lists:

• 11,960,623 cartons
• 12,460,649 individual bottles

Note: The exact product names and lot numbers are listed in the FDA enforcement report and in the infographic below. If you have Rohto eye drops, check the label against that list.

What Should You Do If You Have These Eye Drops?

Follow these steps to stay safe:

1. Stop using the eye drops immediately.
2. Check the product name and lot number on the bottle or carton against the FDA’s recall list.
3. Return the product to the store where you bought it.
   • Most stores will give you a refund or exchange.
   • Call your local store first to confirm their return policy for recalled items.
4. If you’ve used the drops and notice any eye redness, pain, discharge, or vision changes, contact your doctor right away.
5. When in doubt, throw it out. It’s not worth the risk.

Important Points to Remember

• This is a voluntary recall by the company, but it’s overseen by the FDA.
• Class II means low risk of serious harm, but infections are still possible.
• Sterility is critical for eye drops because the eye has no skin barrier to block germs.
• You don’t need a prescription to buy these, so many households may have them.
• Always check your medicine cabinet after a recall announcement.

Summary

• Over 12 million bottles of Rohto eye drops recalled nationwide.
• Reason: Possible loss of sterility → risk of eye infection.
• Class II recall → temporary issues possible, serious harm unlikely.
• 8 product types affected, sold over-the-counter everywhere.
• Action: Stop using, check lot numbers, return to store, call doctor if symptoms appear.

FAQ

1. How do I know if my specific bottle is recalled?
Check the product name, lot number, and expiration date on the bottle or box. Compare them to the list in the FDA enforcement report or the infographic from USA TODAY.

2. Can I get my money back?
Yes. Most retailers will refund or exchange recalled products. Call the store where you bought them to ask about their process.

3. What does "lack of assurance of sterility" actually mean?
It means the company cannot guarantee the drops stayed completely germ-free during manufacturing or packaging. There’s a chance bacteria or fungi got in.

4. I used the drops and feel fine. Should I still worry?
If you have no symptoms, you’re likely okay. But watch for redness, pain, blurry vision, or discharge over the next few days. If anything seems off, see a doctor.

5. Are other brands of eye drops affected?
No. This recall is only for specific Rohto products. Other brands are not part of this announcement.