FDA Announces Nationwide Eye Drops Recall Due to Fungal Contamination
Mar. 15, 2025Stock image of eye drops.Photo:Getty Stock Photo
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Getty Stock Photo
The company Alcon Laboratories, maker of a popular brand of eye drops, recalled some of its nationwide stock on Dec. 23, after discovering a fungal contamination in one of its products.
But, the FDA noted, “To date, Alcon Laboratories has not received any reports of adverse events related to this recall."
Systane eye drops that have been recalled.FDA
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FDA
An Alcon spokesperson told PEOPLE it 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.
The affected product is sold as 25 single-use sterile vials of solution, which consumers can use for temporary relief of burning eyes and irritation. But, per FDA’s recall announcement, a fungal contamination like those found in recalled products could cause eye infections that may be vision-threatening and, in rare circumstances, life-threatening for those who are immunocompromised.
Alcon said that Lot 10101 has an expiration date of 2025/09, and that the lot number and expiration dates are indicated on the product’s packaging. If a consumer has purchased the recalled product, the FDA advises they stop using the product immediately and return it to their point of purchase for a refund or replacement.
Eye drops that have been recalled.FDA
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The company also noted that it was reaching out to its distributors to advise them to dispose of any of their remaining stock of the recalled products.
He added that the company’s recall was done “out of an abundance of caution to prioritize consumer safety.”
In the statement to PEOPLE, the Alcon spokesperson said, “Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies. "
source: people.com
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