FDA official reports or press releases

Alcon Recalls Systane Lubricant Eye Drops Ultra PF, Lot 10101, Nationwide Due to Fungal Contamination

Dec 24, 2024, 05:31 PM

Alcon Laboratories, based in Fort Worth, Texas, has issued a voluntary recall of a single lot of Systane Lubricant Eye Drops Ultra PF due to potential fungal contamination. The affected product, sold in 25 single-use 'on-the-go' vials, was distributed nationwide to retail and online outlets including Walgreens, CVS, and Target. The recalled lot, identified by lot number 10101 and an expiration date of September 2025, was recalled after a consumer reported finding foreign material in a sealed vial, which was later confirmed to be fungal. The FDA warns that fungal contamination in eye products can lead to serious eye infections, potentially causing partial vision loss, blindness, or in rare cases, life-threatening conditions for immunocompromised individuals. No adverse events related to this recall have been reported to date. Consumers are advised to stop using the recalled eye drops immediately and return them to the place of purchase for a replacement or refund.