Potential 'fungal contamination' leads to nationwide recall of popular brand of eye drops: FDA
A popular brand of eye drops is being recalled nationwide due to a possible contamination, which may cause vision damage, according to the Food and Drug Administration (FDA).
On Monday, the FDA announced that Alcon Laboratories, based out of Texas, was voluntarily recalling a single lot of "Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go" as the products may be contaminated with fungus.
The company reported a consumer complaint that a "foreign material" was found inside a sealed single-use vial and determined the material to be "fungal in nature."
Fungal contamination in eye products are known to potentially cause eye infections, the FDA said.
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If an infection occurs, the FDA said it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.
To date, the FDA said that Alcon Laboratories has not received any reports of adverse events related to this recall.
The FDA says the affected product includes the Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count and that it is limited to lot number 10101, expiration date 2025/09.
The product can be identified by the green and pink carton design, the presence of "Systane" and "ULTRA PF" brand names on the front of the carton, and the "25 vials" package size, the FDA explained in a press release.
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The lot of the potentially affected eye drops were also distributed nationwide to retail and internet outlets.
Consumers who have the recalled eye drops are urged to stop using them immediately and return them to the place of purchase for a replacement or refund, the FDA said.
Distributors or retailers who have the recalled eye drops are also being urged to discard any remaining stock of the tainted product.
Alcon Laboratories is also notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products.
This latest recall comes as several eye products over the last year have been pulled from shelves due to the potential risk of infection.
In February, eye ointment products sold at CVS and Walmart stores nationwide were recalled after the FDA discovered a "lack of sterility assurance" at the manufacturing facility.
The four impacted products, which are intended to be sterile, are sold under the brand names Equate, CVS Health and AACE Pharmaceuticals, and have expiration dates ranging from February 2024 to September 2025. The products were distributed nationwide to wholesalers, retailers and through the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
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In November 2023, Kilitch Healthcare India Limited voluntarily recalled 27 eyedrops, all of which were listed on the FDA's rolling list of products that may be contaminated with bacteria, posing a risk of eye infection and vision loss.
None of the aforementioned recalls have been tied to the outbreak of antibiotic-resistant bacteria pseudomonas aeruginosa linked to eye products by Global Pharma Healthcare.
Fox News Digital's Daniella Genovese contributed to this report.