Rohto is recalling nearly 12 million bottles of Rohto Cooling Eye Drops after concerns that the products may not meet sterility requirements. According to FDA classification, the recall is listed as a Class II action, which indicates the products could cause temporary adverse effects but are not expected to result in serious or life-threatening harm.
The recall covers eight specific Rohto Cooling Eye Drops products. The affected bottles have expiration dates ranging from July 2025 through February 2029. The issue prompting the recall relates to sterility, meaning the company and regulators are addressing a risk that the eye drops may not be free from microbial contamination.
The FDA’s classification does not suggest that serious harm is likely, but it signals that consumers should take the recall seriously and follow any instructions provided by Rohto and the FDA. The reports describe the recall as an FDA-driven safety measure tied to sterility concerns rather than performance or ingredient changes.
