Recalled Systane, GenTeal Tears Eye Products Falsely Labeled as ‘Sterile’ Despite Contamination Risks, Class Action Claims

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A proposed class action lawsuit alleges that certain Systane and GenTeal Tears eye-care products were falsely touted as sterile despite manufacturing contamination issues that culminated in a nationwide recall of the items in April 2026.

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The 21-page lawsuit against Alcon Laboratories and its research arm contends that Alcon has deceived consumers by explicitly labeling its Systane Night Gel Comforting Dry Eye Relief and GenTeal Tears Lubricant Eye Gel products as sterile and safe for ophthalmic use. However, both products were recalled last month due to a “lack of assurance of sterility” found after a Food and Drug Administration inspection at an Alcon contract manufacturing facility in France.

“Using non-sterile eye products carries a severe risk of introducing bacteria or fungi directly into the eye, which can cause serious, vision-threatening infections,” the case reads.

According to the complaint, an FDA inspection of the facility in France uncovered “shocking failures” in basic aseptic manufacturing practices, including cracked and damaged equipment used in sterile production lines and the presence of dangerous mold species in areas exposed to the products.

As a result of the investigation, the case says, the FDA published a widespread Class II product recall initiated by Alcon covering the company’s Systane Night Gel Comforting Dry Eye Relief and GenTeal Tears Lubricant Eye Gel eye-care products sold nationwide at retail stores and pharmacies, including CVS.

Related Reading: Systane Eye Drop Recall Lawsuit Filed Against Alcon Over Fungal Contamination Risk

The suit further claims that the alleged contamination concerns were not isolated incidents, referencing mold-related issues on aseptic filling lines dating back to 2022.

Consequently, the suit contends, Alcon was or should have been well aware of the ongoing sanitation and sterility concerns at its contracted facility yet continued to market the Systane and GenTeal Tears products at issue as “sterile” without disclosing health risks, in violation of the New York General Business Law.

“This omission leads a reasonable consumer to believe they are purchasing a safely manufactured, sterile ophthalmic product when in fact they are purchasing an adulterated product that poses a significant risk to ocular health,” the filing states.

The complaint asserts that consumers have no reasonable way to independently verify whether eye-care products are truly sterile and must therefore rely on the representations of the manufacturer when making purchasing decisions. The lawsuit argues that any consumer viewing the claim that a product is sterile would have no reason to believe otherwise.

“By explicitly stating the product is ‘STERILE’ while omitting the lack of sterility assurance on the labels of the Products throughout the Class Period, Defendants know that those misrepresentations and omissions are material to consumers since they would not purchase an unsterile eye product,” the complaint summarizes.

The eye drops class action lawsuit seeks to cover all individuals in the United States who purchased the Systane Night Gel Comforting Dry Eye Relief and/or GenTeal Tears Lubricant Eye Gel products during the applicable statute of limitations period.

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