A contamination issue has been identified in a Systane product.
A popular brand of eye drops, Systane Lubricant Eye Drops Ultra PF (preservative-free), is being recalled in the US due to fungal contamination in a single-use vial.
While Alcon Laboratories, the Texas-based manufacturer, notified the federal government on Saturday and the FDA posted the recall on Monday, major US media outlets reported the recall on Wednesday.
Alcon initiated the voluntary recall after a consumer reported foreign material, identified as fungus, within a sealed vial.
Fungal eye infections pose a serious risk, potentially leading to vision loss and even death in immunocompromised individuals. Alcon reports no adverse effects have been reported thus far.
The recall affects Lot 10101, expiring September 2025, sold in 25-vial boxes at retailers including Target, Kroger, Walmart, and Walgreens, and online.
The FDA advises consumers to discontinue use of affected products and return them to the point of purchase for a refund or replacement. Individuals experiencing adverse reactions should report them to the MedWatch Adverse Event Reporting program via online, mail, or fax.