Alcon Laboratories has voluntarily recalled one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level, according to a release from the U.S. Food and Drug Administration. Alcon evaluated a consumer complaint of foreign material observed inside a sealed, single-use vial and determined the material to be fungal in nature. To date, Alcon Laboratories has not received any reports of adverse events related to this recall.

The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date September 2025. This lot was distributed nationwide to retail and internet outlets.

Consumers that have the recalled product lot should stop using them immediately and return to the place of purchase for a replacement or refund. Consumers with questions regarding this recall can contact Alcon Laboratories at 800-241-5999 between 7:30 a.m. and 6 p.m. CST, Monday to Friday. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product.

Alcon Laboratories is notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products. Distributors or retailers should discard any remaining stock from that lot.