FDA warns companies selling unapproved eye products

After contaminated eye drops killed and blinded several consumers earlier this year, the U.S. Food and Drug Administration (FDA) is cautious about any product consumers put in their eyes.

The agency has sent warning letters to eight companies, including CVS and Walgreens, saying the companies are marketing unapproved eye products. The agency says the products are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility. 

“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.” 

Below is a list of the companies receiving warning letters. Clicking on the links will display the warning letters with details about the products in question.

What to do

The FDA says consumers currently using any of these eye products should stop using them and speak to their healthcare provider. The agency said it is particularly concerned that these illegally marketed 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 March, the FDA linked Artificial Tears Lubricant Eye Drops, manufactured by Global Pharma Healthcare and distributed by EzriCare and Delsam Pharma, two at least three deaths and at least eight cases of blindness.

The product, which was recalled in early 2023, was sold by Amazon, CVS, Target and Walmart. The Centers for Disease Control and Prevention (CDC) reported 68 cases of infection 16 states.