Rohto Eye Drops Recall Due to Sterility Concerns

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Russell Maas

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Certain lots of Rohto Arctic, Rhoto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops have been recalled due to sterility concerns, which could pose a potential health risk for users.  

The Rohto eye drops recall was announced by the U.S. Food and Drug Administration on January 16, after the production plant recognized the potential for the eye relief products may be unsanitary for use. To date, no injuries or reports of side effects have been reported.

The recall includes Mentholatum Company’s retail level Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drop made in Vietnam. The affected products have lot numbers with the letter “V” in the code that can be located on the bottom of the carton and also on the bottom of the eye drop bottle. Only products which have the marking “Made in Vietnam” are included in the recall.

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The products were manufactured by The Mentholatum Company which is a Japanese owned manufacturer of nonprescription medication. The eye drops are sold over-the-counter nationwide.

The FDA announced the firm is initiating the recall out of an abundance of caution and is currently sending notification to all distributors and retailers to cease distribution and sale from store shelves.

According to the recall notice, customers with affected products should discontinue using the eye drops and contact The Mentholatum Company Customer Service Department at 1-877-636-2677 for instructions. Customers are also encouraged to report any adverse side effects to the FDA’s MedWatch Adverse Event Reporting program online or by calling (800) 332-1088.

Photo Courtesy of chaseoblack via Flickr CC 2.0

Written by: Russell Maas

Managing Editor & Senior Legal Journalist

Russell Maas is a paralegal and the Managing Editor of AboutLawsuits.com, where he has reported on mass tort litigation, medical recalls, and consumer safety issues since 2010. He brings legal experience from one of the nation’s leading personal injury law firms and oversees the site’s editorial strategy, including SEO and content development.

Tags: Eye Drops, Mentholatum, Rohto Eye Drops
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16 Comments

Esandai
Eye drops almost got me blind. I can barely see anything, always at the Dr. My eyes are watering and my sight is very blurry.
KRISTY
THIS ISN’T A FUNNY MATTER BUT WHAT IS FUNNY IS THAT ARTICLE WAS FROM 2014 & PEOPLE WERE TRIPOIN AFTER READING IT OVER A YEAR OR MORE LATER! LOL! ALL JOKING ASIDE… I HOPE EVERYONE FOUND A SOLUTION & EVERYONE IS HEALTHY.
Doreen
These comments for 2023 do realize this recall date was 2014?
brad
I’ve been using rohto for years now and I have always had perfectly good eyesight in both eyes . and for the past year or so or more I’ve been wondering why eyesight went from having perfectly good eyesight to blurry vision and burning in the eyes I just thought I just needed more eye drops more often but I still have the bottle that has Vietnam on it and the box that came in the receipt but I’ve been buying these for years now and my vision is probably from 2020 to not good…. I need someone to contact me ASAP for this lawsuit
MBX
I’ve been using Rohto eye drops for 9 years. The bottle I’ve had for the last few month have been BURNING my eyes SO extremely bad. Every single time I use them. To the lint where my eyes water with tears steaming down my face. My daughter just told me about an eye drop recall so I looked it up? Any legal recourse we have for this? I’ve also had the puss or crust the day after using them several times. Never even thought it was something wrong.
Nez
Oh Wow! This cause my eye pain! Good thing I search and this come one about recall. The one I bought from 2 months is part of recall! Why CVS didn’t take these off the shelves! Now i thought i had migraines!
Kristina
Bought these and still have them and nothing but eye issues since I used them. Had no idea they were part of recall. Eyes got mucus all the time and now eyes twitch all the time.
Shallen
I bought the Rohto (All in One), due to my allergies and I also wear glasses. I started using this brand for dry/itchy eyes. When I would put the drops in my eyes, my eyes would burn like all get out !! I just thought it was because my eyes were just so dry. After using about half the bottle, even when my eyes weren’t dry, they would still burn like crazy. I now have ALOT of eye flashes, and my eyes just really hurt pretty much all the time. I, obviously, discontinued use of these eye drops, yet my eyes still feel the effects of using this product. I recommend that if you have this brand of drops, throw them away ASAP !!
Carletta
I recently moved to Texas within the last year from Ohio and my eyes became a little dry, so I purchased Rohto eye drops shortly after my move. A few days later my eyes were completely sealed shut with a infected pus/mucus that had to be treated by an eye doctor immediately. I needed refills on this medication after using Rohto because my eyes are still not the same. My eye sockets and lids hurt periodically. I still have the bottle of eye drops rohto which was purchased in Killeen Texas at a dollar general. I also have pictures of my eyes after the infection started and a copy of the prescription that is currently needed for my eyes.
Sarah
Since starting use of Rohto Ice, I have eye flashes.
Gabriella
These eye drops are the cause of my migraines and eye issues. I thought they had taken these off the shelves and stopped manufacturing them w these issue. I bought some yesterday to see. I knew something was wrong when they usually retail for 12.00-15.00, these were 5.00. Who should I contact about this. I let it go before but I will give this my due diligence.
Kasey
I tried these drops about a year ago i used them like 20 times in a few months forgot about them and ever since ive been having major eye irritation dry eye goopy one minute dry the next i keep thinking i a got hair in my eye and never find one ive never had issues like this before. I picked some up the other day thinking they might help and found out about the recall .. now om worried these drops are what started all this 🙁
Rogelio
My eyes reply are bad due to these drops.my eyes are in alot of pain
ronald
Used drops for two weeks and from a lump on my eye, going through surgery next week .
John
I used Rohtos for at least 3 years. Recently i was diagnosed withwith an Adie’s pupil. I had to go get an MRI to be sure i didn’t have a tumor in my brain or anything. It effects my life big time. Can i sue them for this?
Justen
I started using Rohtos and I used them every day and my eyes are starting to get really red and I was getting headaches and I had no idea what was doing it,it never did that before and then I heard about this Rotas lawsuit. I’m pissed and ever since I stopped using Rohtos I don’t get headaches but my eyes are never going to be the same they have been damaged big time from using I even saw a eye doc and my eyes are horrible now they would be so red it would hurt there was nothing that would make my eyes white again unTil I went to sleep

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