FDA Flags Over 3 Million Bottles of Eye Drops. Is Yours Affected?

The FDA issued a voluntary recall of more than 3 million bottles of eye drops sold at major retailers like Walgreens and CVS. Hitoshi Nishimura/Getty Images More than 3.1 million bottles of over-the-counter eye drops are being recalled due to concerns about sterility. While no illnesses have been reported, experts say recalls like this can erode public trust in medicine. A 2023 outbreak linked to eye drops resulted in more than 80 infections and four deaths in the United States. A California-based pharmaceutical company is recalling more than 3.1 million bottles of eye drops due to concerns about sterility. According to a report by the Food and Drug Administration (FDA), K.C. Pharmaceuticals is conducting a voluntary recall of the products distributed through major national retailers, including Walgreens, Kroger, and CVS. The recall was initiated on March 3 and classified by the FDA on March 31. The FDA safety alert reflects both uncertainty and caution, according to experts. “We don’t know if they really were contaminated. If they were, we don’t know what type of microbe. We don’t know any of that. All we know is that the manufacturer said there’s an issue with sterility in these products,” said Gary Novack, PhD, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science and a consultant in ophthalmic product development. Which eye drop brands were recalled? There have been no reported injuries or illnesses related to the recalled products, which include: Sterile Eye Drops AC Eye Drops Advanced Relief Dry Eye Relief Eye Drops Ultra Lubricating Eye Drops Sterile Eye Drops Original Formula Sterile Eye Drops Redness Lubricant Sterile Eye Drops Soothing Tears Artificial Tears Sterile Lubricant Eye Drops Consumers are urged to discontinue use and discard these products. The FDA classified the recall as a “Class II” recall, meaning that “using the drug may cause temporary health consequences, but the probability of a serious health is