07/30/2026
"Nearly 12 million cases of Rohto eye drops distributed nationwide have been recalled due to sterility issues, according to a Food and Drug Administration report.
The recall covers eight Rohto cooling eye drop products distributed nationwide. The FDA classified it as a Class II recall, meaning the products could cause temporary or medically reversible health effects, though serious injuries are considered unlikely. Consumers should stop using the recalled products and check the FDA's website for affected product names and lot numbers."
The Food and Drug Administration has recalled nearly 12 million Rohto eye drop products nationwide after determining the manufacturer could not assure the products were sterile.