A class-action lawsuit, filed last month, claims Alcon Laboratories falsely marketed two over-the-counter (OTC) products as sterile—despite manufacturing contamination issues and in the wake of a recent nationwide eye drop recall.
Lots to unpack here … starting with that recall.
The situation in question stemmed from a May 2025 warning letter issued by the FDA to Excelvsion Fareva, a France-based manufacturer of several major eye drop brands—including those under the Alcon name.
The letter, sent following the federal agency’s November 2024 (as well as a July 2023) inspection of the manufacturing facility, identified violations in three major categories:
- Mold contamination and inadequate investigations
- Faulty aseptic (sterile) processes
- Inadequate cleaning and equipment maintenance
The potential risk for such violations could include eye infections and vision-(or even life-) threatening consequences for some patients.
And for some background: The manufacturer had previously (in December 2024) responded to the FDA’s inspection findings; however, the federal agency deemed Excelvision’s response “inadequate”—and thus the May 2025 letter was sent.
Hold up—if this letter was sent in May 2025, why the delay in a product recall?
Good question. According to the FDA (in its letter), Excelvision reportedly stated that it would cease production on its affected traditional filling lines.
- As such, the agency didn’t see reason to initiate a recall.
But fast-forward to January 2026: The FDA re-inspected Excelvision’s manufacturing facility.
Those results: 11 new citations over procedural violations, with six of those related to (once again) aseptic processing and microbiological contamination.
Which brings us to that April 2026 recall?
Indeed. Alcon—along with other companies and their respective eye drop brands (such as Harrow Eye LLC; OASIS Medical, Inc.; Thea Pharma, Inc.; and SCOPE Health)—were included in the Class II recall.
Specifically, Alcon Research LLC voluntarily recalled two products:
- Genteal Tears Lubricant Eye Gel (all unexpired lots)
- Systane Night Gel Comforting Dry Eye Relief (all unexpired lots)
Additionally: The FDA also placed Excelvision on an FDA Import Alert in late April for all drug products, effectively barring them from entering the U.S. commercial market space.
Gotcha. Now circle back to this lawsuit.
When and where: Filed on May 14 in the U.S. District Court for the Eastern District of New York as a “putative class action” (see what this means).
- The plaintiff: Bibi Khan (a consumer who purchased the aforementioned products at a CVS location) of Nassau County, New York.
- The defendants: Alcon Laboratories, Inc. and Alcon Research, LLC.
So what led this plaintiff to file?
Per the suit, the plaintiff purchased one unit of the two recalled Alcon products (Systane Night Gel eye gel) at CVS Pharmacy in New York—which she would not have done had she known of the lack of sterility assurance.
The crux of her argument: Alcon improperly, deceptively, and misleadingly labeled and marketed its products by explicitly labeling them as "sterile" while omitting and not disclosing to consumers that the products lacked an assurance of sterility.
So she didn’t purchase GenTeal Tears as well?
No—although purchasers of that product are also included in the lawsuit, as it claims the product is “substantially similar to the Systane Night Gel.”
As the suit notes: “Both products are (OTC) ophthalmic gels sold by (Alcon), manufactured at the same Excelvision facility, labeled as ‘sterile,’ and suffer from the exact same manufacturing defect rendering them unsterile.”
And how does the “class action” component come in?
The suit noted that all purchasers of the recalled Alcon products suffered economic injury either through loss of value or paying extra based on allegedly false representations.
The proposed class for this extends to all individuals within the United States who purchased the affected Alcon products during “the applicable statute of limitations period”—a number that may reach into the thousands, the plaintiff noted.
A New York subclass is also included in this, applying to those within New York state “who purchased defendants’ affected products.”
Let’s talk about these accusations.
With the FDA’s manufacturing contamination findings from its Exelvision inspections—as well as the subsequent recall—as its backdrop, the lawsuit alleges that certain bottles of Alcon’s Systane and GenTeal Tears products were manufactured under unsanitary conditions.
Get a little more specific.
The plaintiff accuses Alcon of deceiving consumers by explicitly labeling the two products as sterile and safe for ophthalmic use—and that the company sold them without an affirmative assurance of sterility.
- “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 lawsuit states.
Even further: These contaminations aren’t exactly isolated, as Excelvision faced similar issues following an FDA inspection of its facilities in 2022.
Check out (starting on page 13) all five legal claims the plaintiff is alleging.
- Among them: failure to disclose a lack of sterility assurance, false advertising, and negligence.
And why is Alcon at fault for this?
Because, according to the lawsuit, the company not only relies on Excelision to produce its products, but it also had knowledge of the risks involved in the production and manufacturing of their respective products—knowledge that wasn’t made readily available to consumers.
“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 suit stated.
Alrighty, so what is the lawsuit asking of the court?
Aside from an official certification as a class action lawsuit (which would allow representation of all U.S. consumers and that aforementioned New York group), the suit requested:
- To pay back consumers for the money spent on Alcon’s two products—and then some (for punitive damages)
- That Alcon be forced to stop selling products labeled as “sterile” that can’t actually be guaranteed as sterile
- Coverage for all legal costs, in which Alcon would pay lawyer fees, expert witness costs, and other expenses incurred from the case
- Alcon pay added interest on what it owes, from the time the harm occurred up to when the judgement is paid
- Anything else the court sees fit to order
The bottom line: The plaintiffs want their money back, they want Alcon to be penalized, and they want the court to ensure this doesn't keep happening to other consumers.
Duly noted. Now the big question: Has Alcon responded to this lawsuit?
Glance reached out to the company for comment. As of June 4, we have not yet heard back.
Generally speaking, however, companies don’t typically comment on new lawsuits.
Stay tuned for a potential formal response (or even a motion to dismiss).