Walgreens and CVS Under Investigation by FDA for Selling Unapproved—and Potentially Unsafe—Eye Drop Products

Schubert Jonckheer & Kolbe LLP launched an investigation into Walgreens and CVS after the U.S. Food & Drug Administration issued warning letters to manufacturers of eye drop products. Walgreens and CVS marketed certain non-FDA approved eye drop products as treatment for medical conditions.

These products include:

• Walgreens Allergy Eye Drops

• Walgreens Stye Eye Drops

• Walgreens Pink Eye Drops

• CVS Health Brand Pink Eye Relief Eye Drops

Walgreens and CVS marketed certain eye drop products as treatments for medical conditions such as conjunctivitis, cataracts, and glaucoma. However, according to the FDA, these products are “drugs” under the Food, Drug, & Cosmetic Act, which. defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

On September 12, 2023, the FDA announced that it was “particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses”. In its warning letter to Walgreens, the FDA noted that Walgreen’s ophthalmic drug products utilize silver sulfate as a preservative. This is a concern because long term use of medicinal compounds containing silver may cause argyria (a blueish-gray discoloration of the skin and eyes that is irreversible). It may also cause adverse effects on night vision.

In light of these concerns, the Schubert Firm is investigating whether CVS and Walgreens have violated state and federal laws by selling unapproved—and potentially unsafe—eye drop products. If you purchased one of these products, you may be entitled to a refund and an injunction requiring CVS and Walgreens to stop selling them.

If you have purchased any of the above eye drops from CVS and Walgreens and wish to obtain additional information about your legal rights, please complete the form below for a free legal consultation.