FDA Expands Eye Drop Recall to Over 3 Million Bottles Due to Sterility Issues
The FDA has expanded a recall involving more than 3 million bottles of eye drops manufactured by K.C. Pharmaceuticals, Inc. The recall, initiated on March 3, 2026, is due to a lack of assurance of sterility, which poses potential health risks to consumers. The affected products were distributed to major retailers, including Walgreens, CVS, and Rite Aid. The recall has been classified as Class II, indicating that while serious health consequences are considered remote, temporary or medically reversible adverse effects may occur. The recall includes various eye drop products such as Dry Eye Relief Drops and Artificial Tears Sterile Lubricant Eye Drops.