One lot of Systane brand eye drops were voluntarily recalled due to possible fungal contamination, the United States Food and Drug Administration announced earlier this week.
Systane Lubricant Eye Drops Ultra PF were recalled after a customer complaint of “foreign material observed inside a sealed single use vial,” the FDA said. The material was determined to be fungal in nature.
The eye drops recalled, used to treat symptoms of dry eye, were sold in 25-count on-the-go single vials with lot number 10101 and an expiration date of September 2025.
Fungal contamination of an eye product is known to potentially cause eye infections.
“If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the FDA noted on its website.
Alcon Laboratories, the company that manufactures Systane, has not received any reports of adverse events related to this recall.
Customers who have the recalled drops should stop using them immediately and return to the place of purchase for a replacement or refund, the FDA added. If you have experienced any problems that may be related to using this product, the FDA advises contacting your physician.
Consumers with questions regarding this recall can contact Alcon Laboratories at 1-800-241-5999.
Adverse reactions or quality problems with this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or fax.
In 2023, eye drop recalls made headlines for weeks after bacterial contamination caused dozens of products to be recalled.
