articleNearly 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 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. The eye drops were manufactured by Rohto-Mentholatum in Vietnam and distributed by The Mentholatum Company, based in Orchard Park, New York.