Key Takeaways More than 3.1 million bottles of store-brand eye drops have been recalled nationwide due to concerns about product sterility The FDA classified the recall as Class II, meaning the products could cause temporary or reversible health effects, though serious harm is unlikely Consumers should check their eye drops’ lot numbers and expiration dates and stop using any products included in the recall More than 3.1 million bottles of over-the-counter eye drops sold at major retailers across the United States—including CVS, Walgreens and Kroger—have been recalled over safety concerns, according to FDA guidance. The recall, issued by California-based manufacturer K.C. Pharmaceuticals (KCP), stems from what the FDA described as a “lack of assurance of sterility,” meaning the products may not be guaranteed free from potentially harmful microbes. According to its website, KCP is the largest private label eye care supplier for eye care and lens care products in North America. The company services 26 out of 30 top US largest retailers. The FDA said the recall affects more than 3.1 million bottles spanning at least eight types of eye drop products. The drops—which include artificial tears, dry eye relief drops, redness relief drops, and lubricating eye drops—are sold under a wide range of store-brand labels. The recalled products are: Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottles Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 fl oz (15mL) bottles Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles The recall has been classified as a Class II recall, indicating that use of the products could cause temporary or medically reversible health problems, though the likelihood of serious harm is considered low. Health officials emphasized that no confirmed cases of contamination or injuries have been reported so far. However, because eye drops are applied directly to sensitive tissue, even a small risk of contamination can pose potential dangers, including irritation, infection or vision complications. Consumers are being urged to check their medicine cabinets and review product labels, including lot numbers and expiration dates, to determine whether their eye drops are affected. The FDA advises that: Affected products should not be used if identified as part of the recall Consumers can return items to the place of purchase or dispose of them safely Anyone experiencing symptoms such as eye pain, redness or vision changes should seek medical attention