A popular eye drop product is being recalled

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

On Monday, the FDA announced that Alcon Laboratories, based in Texas, is voluntarily recalling one lot of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go” because the products may be contaminated with mold.

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

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

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

So far, the FDA said Alcon Laboratories has received no reports of adverse events related to the recall.

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

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

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“Systane Lubricant Eye Drops Ultra SPF, Single Containers On-the-Go” has been recalled as the products may be contaminated with mold, according to the FDA. (Food and Drug Administration (FDA) / Fox News)

Dozens of potentially affected eye drops were also distributed across the country in stores and online.

Consumers with 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 with recalled eye drops are urged to dispose of any remaining stock of the contaminated product.

Alcon Laboratories also notifies its distributors and customers by letter, email, and/or telephone and arranges for replacement of all returned products.

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

The latest recall comes as several eye products have been pulled from shelves in the past year due to the potential risk of contamination.

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

Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra PF following a consumer complaint of a foreign material that could not be seen inside the sealed bottle. (Food and Drug Administration (FDA) / 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 from February 2024 to September 2025. The products were distributed nationwide to wholesalers, retailers and through a distributor of the brand, 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 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 above is tied to the outbreak of antibiotic-resistant bacteria. pseudomonas aeruginosa linked to eye products by Global Pharma Healthcare.

Daniella Genovese of Fox News Digital contributed to this report.