Rohto Eye Drops Recall Due to Sterility Concerns

  • Written by: Russell Maas

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.

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

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  1. Justen Reply

    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

  2. John Reply

    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?

  3. ronald Reply

    Used drops for two weeks and from a lump on my eye, going through surgery next week .

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