Alcon Laboratories, the maker of the popular Systane eye drops, issued a recall of one lot of its Systane Lubricant Eye Drops Ultra PF on December 23 due to a potential fungal contamination. The recall comes after a consumer complaint led to the discovery of foreign material in a sealed single-use vial.
According to the Food and Drug Administration (FDA), the substance was confirmed by Alcon to be fungal in nature. While no adverse events have been reported to date, Alcon initiated the voluntary recall “out of an abundance of caution.”
The recalled product, Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, is sold in 25-count packages with Lot 10101 and an expiration date of September 2025. Consumers who have purchased the affected product are advised to stop using it immediately and return it to the point of purchase for a refund or replacement.
Alcon is working with distributors to remove any remaining stock of the recalled product from shelves. Stores impacted by the recall include Kroger locations in multiple states, as well as Fred Meyer, Ralphs, QFC, and Publix.
The FDA warned that fungal contamination in eye drops could lead to eye infections, which may be vision-threatening or, in rare cases, life-threatening for immunocompromised individuals.
Alcon emphasized its commitment to safety, with spokesperson Steven Smith noting that the contamination appears to be isolated to a single unit but adding that the recall prioritizes consumer well-being. “Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies,” Smith said.
Consumers with questions about the recall can contact Alcon or the FDA for further guidance.
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