The FDA has issued a recall for specific lots of Systane eye drops due to potential fungal contamination after a consumer complaint. Users are advised to stop using the product immediately and return it for a refund or replacement.

In response to a report of foreign material found in a sealed vial, Alcon Laboratories has initiated a voluntary recall of Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count.

The foreign material was found to be “fungal in nature” which can cause an eye infection that could threaten a person’s vision. It also can be potentially life-threatening. There have not been any reports of adverse reactions connected to the drops.

Hawai‘i DOH warns against a contaminated lot of Systane Lubricant Eye Drops that could cause severe eye infections.

One lot of Systane Lubricant Eye Drops Ultra PF, manufactured by Alcon Laboratories, has been recalled due to fungal contamination, the FDA announced this week.

Fungal contamination of an eye product is known to potentially cause eye infections​​, which may be vision- or life-threatening, according to the FDA.

A Texas -based company has voluntarily recalled their Systane-brand eye drops over possible fungal contamination. Alcon Laboratories in Fort Worth, Texas recalled one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count on December 21. The recall impacts Lot 10101 with an expiration date of September 2025.