Nearly 12 million bottles of Rohto eye drops have been recalled over concerns they may not be sterile, according to a Food and Drug Administration (FDA) enforcement report. The voluntary recall was issued by Vietnam-based Rohto-Mentholatum and includes eye drops marketed to relieve redness, dryness and eye strain. According to the FDA, the recall affects 11,960,623 cartons of Rohto Cooling Eye Drops distributed nationwide. The FDA said the products were recalled because of a "lack of assurance of sterility," meaning the eye drops cannot be guaranteed to be free of potentially harmful microorganisms. The recall covers eight Rohto Cooling Eye Drops products — including ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief — in single and twin-pack configurations.