The popular brand of eye drops is being recalled

According to the Food and Drug Administration (FDA), a popular brand of eye drops is being recalled nationwide due to possible contamination, which can cause vision damage.

On Monday, the FDA announced that Texas-based Alcon Laboratories was voluntarily recalling Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go because the products may be contaminated with fungus.

The company reported a consumer complaint that a “foreign material” was found inside a sealed single-use bottle and determined that the material was “fungus in nature.”

Fungal contamination in eye products is known to cause eye infections, the FDA said.

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If an infection occurs, the FDA said it can be sight-threatening and in very rare cases potentially life-threatening in immunocompromised patients.

The FDA said that to date, Alcon Laboratories has not received any reports of adverse events related to this recall.

The FDA said the affected product includes Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count and that it is limited to lot number 10101, expiration date 09/2025.

The product can be identified by the green and pink carton design, the presence of the brand names “Systane” and “ULTRA PF” on the front of the box, and the “25 vial” package size, the FDA explained in a news release.

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Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go have been recalled because the products may be contaminated with fungus, according to the FDA. (Food and Drug Administration / Fox News)

A large portion of the affected eye drops were also distributed nationwide at retail outlets and online.

Consumers who have recalled the eye drops are asked 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 recalled eye drops are also asked to dispose of any remaining stock of the contaminated product.

Alcon Laboratories is also notifying its distributors and customers by letter, email and/or telephone and is making arrangements to replace all recalled products.

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Alcon Laboratories issued the recall after a consumer complained of a “foreign material” they found in a sealed bottle of eye drops. (Food and Drug Administration / Fox News)

This latest recall comes after several eye products have been pulled from shelves over the past year due to the potential risk of infection.

In February, eye oil products sold at CVS and Walmart stores nationwide were recalled after the FDA found a “sterility assurance deficiency” at the manufacturing facility.

Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra PF after a consumer complaint of foreign material being observed inside a sealed bottle. (Food and Drug Administration / Fox News Latino)

The four affected 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, retail 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 eye drops, all of which were listed on the FDA’s 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 linked to outbreaks of antibiotic-resistant bacteria pseudomonas aeruginosa related eye products from Global Pharma Healthcare.

Fox News Digital’s Daniella Genovese contributed to this report.