FDA Announces Recall of Nearly 12 Million Rohto Eye Drops Over Sterility Concerns
The Food and Drug Administration (FDA) has announced a recall of nearly 12 million bottles of Rohto eye drops due to concerns over their sterility. The recall, initiated by Vietnam-based Rohto-Mentholatum, affects products marketed for relieving redness, dryness, and eye strain. The FDA's enforcement report indicates that the recall involves 11,960,623 cartons of Rohto Cooling Eye Drops distributed across the United States. The recall was prompted by a 'lack of assurance of sterility,' meaning the eye drops may not be free from potentially harmful microorganisms. The affected products include various Rohto Cooling Eye Drops such as ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, available in single and twin-pack configurations. These products have expiration dates ranging from July 2025 to February 2029. Consumers are advised to check the lot number and expiration date on their packaging against the manufacturer's recall notice or the FDA's website to determine if their product is...