Class Action Targets 'Sterile' Labeling on Eye Drops Amid Safety Concerns
A class action challenges two eye gels' 'sterile' labeling, citing contamination risks and false advertising.
Why it matters: Legal scrutiny over 'sterile' claims could reshape advertising standards, regulatory compliance, and product liability in the pharmaceutical sector. Healthcare companies may face growing pressure to substantiate safety assurances and labeling practices.
- The lawsuit, filed May 15, 2026, alleges manufacturers mislabeled ophthalmic gels as 'sterile.'
- Alcon Laboratories recalled Systane eye drops in February 2025 due to fungal contamination and faced a separate class action.
- Similasan Corp. settled in July 2025 for $3.575 million over allegedly deceptive 'sterile' eye drop claims.
- Allergan USA was sued in 2026 for purportedly mislabeling eye drops as 'preservative-free.'
A recently filed class action claims two ophthalmic lubricant gels were falsely marketed as 'sterile,' arguing the products were not guaranteed free of bacteria and fungi that could cause infection. The suit, filed May 15, 2026, reflects broader legal concern over pharmaceutical marketing regarding product safety.
- Legal documents allege the manufacturer’s uniform misconduct led to injuries among all class members, calling the 'sterile' labeling deceptive and misleading.
- This case joins a pattern of recent lawsuits over eye care product claims. In February 2025, Alcon Laboratories recalled a lot of Systane Lubricant Eye Drops Ultra PF over fungal contamination and faced a class action over allegedly misleading sterility claims.
- Similasan Corp. agreed to pay $3.575 million in July 2025 to resolve allegations that its homeopathic eye drops used deceptive 'sterile' and 'homeopathic' labeling without warning of possible risks.
- In a related trend, Allergan USA was sued in Illinois in January 2026 for allegedly labeling products as 'preservative-free' while including boric acid.
Allegations in these cases often cite consumer deception and claim that reasonable diligence would have prevented misleading statements. As courts assess the validity of sterility and safety claims, pharmaceutical companies face mounting pressure to rigorously substantiate product labels—not just to satisfy regulators, but also to minimize litigation risk.
By the numbers:
- $3.575 million — Similasan Corp. settlement over deceptive 'sterile' labeling in July 2025
- 1 lot — Systane eye drops recalled in February 2025 over fungal contamination