FDA investigation results or public statements

Alcon Recalls One Lot of Systane Eye Drops Nationwide Due to Fungal Contamination, FDA Warns of Vision-Threatening Risks

Dec 26, 2024, 07:01 PM

Systane brand eye drops have been recalled nationwide due to possible fungal contamination, according to an announcement from the Food and Drug Administration (FDA). The recall affects one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, after a consumer reported finding a foreign material in a sealed vial. Upon investigation, the Texas-based manufacturer, Alcon, confirmed that the material was fungal in nature. The FDA has warned that this contamination could lead to eye infections that may threaten vision, particularly in immunocompromised individuals. The recalled eye drops are commonly used for temporary relief of burning and irritation associated with dry eye symptoms and are sold at retailers including Publix and Amazon. Consumers are advised to check their medicine cabinets for the affected product.