FDA Recalls 8 Rohto Cooling Eye Drop Products: What You Need to Know

What Happened?

The U.S. Food and Drug Administration (FDA) — the government agency that makes sure medicines and medical products are safe — has announced a voluntary recall of eight different Rohto Cooling Eye Drop products.

Key Facts at a Glance

• Who recalled them? Rohto-Mentholatum (Vietnam) Co., Ltd. (the manufacturer)
• When? The recall started on July 14
• Who distributes them? The Mentholatum Company (nationwide across the U.S.)
• FDA Classification: Class II — this means using these products might cause temporary or reversible health issues, but the chance of serious harm is considered low.

Why Were These Products Recalled?

The reason is the same for all eight products: "lack of assurance of sterility."

What does "sterility" mean?

When something is sterile, it means it’s completely free from germs (like bacteria, fungi, or viruses). Eye drops must be sterile because they go directly into your eye — one of the most sensitive parts of your body. If germs get in there, they can cause infections, irritation, or even damage your vision.

Since the company cannot guarantee these specific batches are 100% germ-free, they’re being recalled just to be safe.

Which Products Are Affected?

There are 8 different Rohto Cooling Eye Drop products included in this recall. They come in multiple formulations (different ingredients/strengths) and many different lot numbers.

Check the full official list here:
FDA Recall List – Rohto Cooling Eye Drops
(This link takes you directly to the FDA’s searchable database with every affected product, UPC, and lot number.)

What Should You Do?

Follow these steps right away if you use Rohto Cooling Eye Drops:

Step-by-Step Checklist

1. Find your bottle — Check your medicine cabinet, purse, backpack, car, or anywhere you keep eye drops.
2. Locate the UPC and Lot Number — These are printed on the box and/or the bottle label.
   • UPC = the barcode number (usually 12 digits)
   • Lot Number = a code like "ABC123" that identifies when/where it was made
3. Compare with the FDA list — Go to the link above and search for your product’s UPC and lot number.
4. Check the expiration date — Affected lots expire between July 2026 and February 2029. Even if yours isn’t expired yet, it could still be recalled.
5. If it matches — STOP USING IT IMMEDIATELY
   Do not use even one more drop.
6. Contact the company or your doctor — If you have questions, call the manufacturer (info on the FDA list) or ask your healthcare provider.
7. Report any problems — If you’ve had redness, pain, vision changes, discharge, or any weird symptoms after using these drops, report it to the FDA’s MedWatch program:
   • Online: fda.gov/safety/medwatch
   • Phone: 1-800-FDA-1088

IMPORTANT REMINDER

Eye infections can get serious fast. Even if the risk is labeled "low," your eyes are precious. Don’t take chances. If your product is on the list, throw it out or return it — and switch to a different brand until this is resolved.

Summary

• The FDA has recalled 8 Rohto Cooling Eye Drop products due to possible sterility issues.
• The recall began July 14 and affects products sold nationwide.
• The risk is Class II — temporary/reversible problems possible, serious harm unlikely but not impossible.
• Check your bottles using the UPC and lot number on the FDA recall list.
• Stop using immediately if yours is recalled.
• Report any side effects to FDA MedWatch (online or 1-800-FDA-1088).
• When in doubt, ask your doctor or pharmacist — they can help you pick a safe alternative.

Frequently Asked Questions (FAQ)

1. How do I find the UPC and lot number on my eye drops?

Look at the bottom or side of the box and the label on the bottle itself. The UPC is the long barcode number (12 digits). The lot number is usually a shorter code like LOT: 24F123 or EXP 07/2027 / LOT 8891. If you threw away the box, check the bottle — it’s often printed near the expiration date.

2. What if I already used the recalled drops and feel fine?

That’s great! But stop using them now. Some eye infections take a few days to show symptoms. Keep an eye out (pun intended ) for redness, pain, blurry vision, light sensitivity, or goop/discharge. If anything feels off, call your eye doctor or regular doctor right away.

3. Can I return the recalled product for a refund?

Yes! Most recalls include a refund or replacement. Check the FDA recall page for the manufacturer’s contact info, or call the store where you bought it (CVS, Walgreens, Walmart, Amazon, etc.). They usually honor recalls even without a receipt.

4. Are all Rohto eye drops recalled?

No. Only 8 specific Rohto Cooling Eye Drop products with certain lot numbers are affected. Other Rohto products (like Rohto Dry-Aid, Rohto Hydra, etc.) and other lot numbers of the same product are not part of this recall. Always verify using the FDA list.

5. Why does the FDA use "Class II" — what are the other classes?

Good question! The FDA has three recall classes:

• Class I: Dangerous — could cause serious harm or death (highest risk)
• Class II: This recall — might cause temporary/reversible issues, serious harm unlikely
• Class III: Low risk — unlikely to cause any health problem (usually labeling errors)

This is a middle-level recall — serious enough to act on, but not an emergency panic situation.

Stay safe, check your drops, and when in doubt — ask a pro!