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The Food and Drug Administration Recalls Over 12 Million Bottles of Rohto Cooling Eye Drops Due to Sterility Concerns

The Food and Drug Administration announced a voluntary recall of over 12 million bottles of Rohto Cooling Eye Drops sold nationwide. The recall, initiated by the manufacturer Rohto-Mentholatum, affects 11,960,623 cartons of eight different varieties of the medication. The products were recalled due to a "lack of assurance of sterility," meaning the bottles may not be guaranteed free from potentially harmful microbes. Because eye drops are applied directly to the eye, maintaining sterility is essential. The FDA designated this as a Class II recall, indicating that while the user may experience temporary or reversible health effects, the risk of serious complications is considered remote. Consumers are advised to stop using the recalled products immediately. Customers can check their specific lot numbers and expiration dates, which range from July 2026 to February 2029, against the official recall list. Affected bottles can be returned to the place of purchase or disposed of by the consumer.

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