A recently filed class action lawsuit alleges that certain over-the-counter eye care products were marketed as sterile despite lacking proper assurance of sterility, raising concerns about consumer safety and product transparency. The complaint was submitted by Bibi Khan in the United States District Court for the Eastern District of New York on May 14, 2026, naming Alcon Laboratories, Inc. and Alcon Research LLC as defendants.
According to the filing, the dispute centers on two specific ophthalmic products: Systane Night Gel Comforting Dry Eye Relief and GenTeal Tears Lubricant Eye Gel. The plaintiff claims these products were labeled as “STERILE” but did not meet necessary sterility standards due to manufacturing deficiencies identified during an inspection by the U.S. Food and Drug Administration (FDA). In April 2026, a Class II recall was initiated by Alcon for both products (Recall Number D-0491-2026), following FDA observations at their contract manufacturing facility in France known as Excelvision Fareva.
The complaint states that consumers who purchased these products reasonably expected them to be safe for use in their eyes and truly sterile as indicated on packaging. "Defendants have improperly, deceptively, and misleadingly labeled and marketed its Products to reasonable consumers...by explicitly labeling the Products as 'STERILE' while omitting and not disclosing to consumers on its packaging that the Products lack an assurance of sterility," according to the court document. The risk cited includes potential introduction of bacteria or fungi into the eye from non-sterile gels—a hazard that could result in serious infections.
The FDA’s inspection reportedly uncovered repeated contamination issues at Excelvision Fareva dating back to 2022. Mold species such as Penicillium citrinum, Fusarium oxysporum, and Aspergillus were found within critical aseptic filling areas where these eye gels are processed. The FDA also documented inadequate corrective actions taken by the facility operator after discovering mold incidents. Other problems included improper aseptic techniques by operators—such as extending non-sanitized forearms near open bottles—and unaddressed equipment defects like scratches or cracks along filling lines.
Plaintiff Bibi Khan alleges she purchased one unit of a recalled product at a CVS Pharmacy in New York with a lot code indicating it was subject to recall. She claims she would not have bought or paid a premium for the product had she known about its lack of sterility assurance: "Plaintiff purchased, purchased more of, and/or paid more for, the Products than she would have had she known the truth about the Products." The suit asserts that all purchasers suffered economic injury either through loss of value or paying extra based on allegedly false representations.
The legal arguments presented include violations of New York General Business Law sections 349 (deceptive acts or practices) and 350 (false advertising), negligence in manufacturing and failing to warn consumers about risks after learning about deficiencies, unjust enrichment from selling adulterated goods at premium prices, and breach of implied warranty of merchantability under state commercial codes.
The proposed class includes all persons in the United States who purchased affected products during relevant periods defined by statute limitations; there is also a New York subclass specified for state residents who made purchases. Plaintiff seeks certification for this class action under Federal Rule 23.
Remedies requested include statutory damages, compensatory damages, restitution for money spent on mislabeled goods, injunctive relief prohibiting further misleading conduct by defendants, attorney fees, interest payments before and after judgment, expert witness fees, costs associated with litigation, incentive awards for class representatives if applicable under law—and any other relief deemed just or proper by the court.
Attorneys listed for Bibi Khan are Brett R. Cohen from Leeds Brown Law P.C., located in Carle Place, New York; and Daniella Levi from Daniella Levi & Associates P.C., based in Fresh Meadows, New York. The case is identified as Case No. 2:26-cv-2900.
Source: 226cv02900_Khan_v_Alcon_Laboratories_Inc_Complaint_Eastern_District_New_York.pdf