More than 3.1 million bottles of over-the-counter eye drops are being pulled from shelves after a California-based pharmaceutical company flagged concerns about whether the products were properly sterilized during manufacturing.
K.C. Pharmaceuticals initiated the voluntary recall on March 3. The FDA classified it on March 31 as a Class II recall, a designation that indicates a product may cause temporary or medically reversible health consequences, but does not confirm that contamination actually occurred. No injuries or illnesses linked to the recalled products have been reported.
Eight product lines are affected, including 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, and Artificial Tears Sterile Lubricant Eye Drops. The products were distributed through major national retailers.
"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, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science and a consultant in ophthalmic product development.
CVS confirmed to Healthline that the four recalled items it carried had been discontinued nearly a year before the recall was announced. The chain said it is cooperating fully with the recall and will issue refunds to customers who purchased the products. Walgreens and Kroger did not respond to requests for comment.
The FDA urges anyone who has these products at home to stop using them and discard them immediately.
Even without confirmed harm, the recall carries broader consequences. Sylvia Groth, executive medical director of the Department of Ophthalmology at Vanderbilt University Medical Center, said recalls like this chip away at something harder to measure than physical injury.
"These events erode patient trust in over-the-counter medications," she said, expressing concern that the fallout could make patients skeptical of treatments their doctors recommend.
That concern is not without precedent. A 2023 outbreak linked to contaminated eye drops resulted in more than 80 infections and four deaths in the United States, a crisis that drew widespread attention to the risks of compromised sterility in ophthalmic products. The current recall has not produced any comparable harm, but regulators and clinicians are treating the potential lapse seriously.
The FDA's Class II classification reflects that posture: not a confirmed danger, but enough uncertainty to justify pulling the products from circulation. For consumers, the guidance is straightforward. Check product names against the recall list, stop using any affected bottles, and contact the retailer for a refund.
