Systane eye drops recalled due to fungal contamination: FDA

(WASHINGTON) — One lot of eye drops is being voluntarily recalled due to potential fungal contamination, the U.S. Food and Drug Administration announced earlier this week.

The eye drops, Systane Lubricant Eye Drops Ultra PF, are single vial drops available in a 25-count box and manufactured by Alcon Laboratories, based in Fort Worth, Texas.

“Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal in nature,” the FDA wrote in its release.

It is unclear what type of fungus the eye drops are contaminated with.

Fungal contaminations of eye products can lead to eye infections, which can result in partial blindness or total blindness. In rare cases, such eye infections can be life-threatening in immunocompromised patients, according to the FDA.

As of Dec. 23, Alcon Laboratories has not received any reports of adverse events related to the eye drop recall.

Systane Lubricant Eye Drops Ultra PF is meant to temporarily relieve burning and irritation in people experiencing dry eye symptoms, according to the FDA.

The FDA recommends any consumers who have the recalled eye drops stop using them immediately and return them to the place of purchase to receive either a replacement or a refund. Distributors or retailers are also advised to discard any boxes in stock with the lot number 10101.

The recall is limited to packages that have the lot number 10101 and are set to expire in September 2025. The FDA said packages were sold nationwide, both in stores and online.

Any consumers who used the recalled product and are experiencing any problems should contact their health care provider immediately, the FDA said.

“Alcon is conducting a voluntary recall of one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) distributed only in the United States following the discovery of foreign material inside a single, unused, plastic unit dose vial returned with a customer-reported complaint,” a company spokesperson told ABC News in a statement.

“Investigation of this event is still ongoing; however, the presence of foreign material appears to be isolated to the single unit returned by a customer,” the statement continued. “To date, there are no adverse events related to this recall. However, out of an abundance of caution, Alcon has initiated a voluntary recall and notified the FDA.  Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies.”

Last year, contaminated eye drops were linked to at least four deaths and 14 cases of vision loss. At the time, patients reported using at least 10 different brands of artificial tears.

At least one set of eye drops was contaminated with an antibiotic-resistant form of Pseudomonas aeruginosa, an aggressive bacterium, according to the CDC.

In November, the FDA announced 27 eye drops products were being recalled due to potential safety concerns “after FDA investigators found insanitary conditions.”

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