Walgreens hit with lawsuit after FDA warning over eyedrops

Walgreens was hit 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.

The lawsuit, filed Wednesday, follows warning letters that the FDA sent to Illinois-based Walgreens and several other companies last week about selling and marketing eye care products that the agency said posed a risk to users. The FDA has not approved the products at issue.

The FDA's 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. The FDA also said that the products contain silver sulfate, a preservative that could have health risks, and that the facility where the products were made did not adhere to safe manufacturing regulations enforced by the agency.
The lawsuit, which focuses on Walgreens’ brand Pink Eye Drops, mirrors the agency’s letter, claiming plaintiff Mandy Wells would not have purchased the product had she known it was not effective or safe. Wells, who seeks to represent a class of Florida Walgreens customers, is seeking unspecified damages.

Representatives for Walgreens did not immediately respond to requests for comment. After the warning letter was released, Walgreens said it had stopped the sale of the unapproved eye drops, and that customers who purchased these products could return them for a full refund.

The FDA asked the companies to respond within 15 days of receipt of the letters with a description of how they will correct the violations.

Wells is represented by Great Neck, New York, attorney Spencer Sheehan, who frequently represents people in class actions claiming product mislabeling. Sheehan, who did not respond to requests for comment, disclosed in another case that he filed more than 500 lawsuits between January 2020 and April 2023.

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