Walgreens is hit with a lawsuit after FDA’s eyedrop warning letter

Walgreens has been served with a proposed class action in Florida federal court over claims it “mislabeled eyedrops for treating pink eye and misled consumers into believing the product was safe and effective,” reports Reuters. 

The lawsuit comes after the FDA sent a warning letter to eight companies last week, pointing to eye products that were being illegally marketed to treat conditions like conjunctivitis, cataracts, and glaucoma. The agency said the products could be harmful to consumers because they can bypass some of the body’s natural defenses.

The lawsuit (filed on Sept. 20) follows the warning letters from the FDA to several other pharma companies including Illinois-based Walgreens. The FDA had not approved the products at issue. 

The lawsuit focuses on Walgreens’ brand Pink Eye Drops, and mirrors the agency’s letter, claiming the plaintiff would not have purchased the product “had she known it was not effective or safe.” The plaintiff seeks to represent a class of Florida Walgreens customers and is seeking unspecified damages.

However, a Walgreens spokesperson told Supermarket News, “Out of an abundance of caution, we are pulling these products. Customers who have purchased these products can return the item to their nearest Walgreens for a full refund.” 

The FDA letter to Walgreens flagged its branded Pink Eye Drops, Allergy Eye Drops, and Stye Eye Drops as the products the company was “illegally marketing as unapproved new drugs,” reported Reuters. 

The FDA also said in the letter that the products contain silver sulfate, a preservative that could pose health risks and that the facility where the products were made did not adhere to safe manufacturing regulations enforced by the agency. The FDA gave the companies 15 days to respond with how they will correct the violations.