FDA Recalls Over 3.1 Million Bottles of Eye Drops Due to Sterility Concerns
The U.S. Food and Drug Administration (FDA) has recalled more than 3.1 million bottles of over-the-counter eye drops manufactured by K.C. Pharmaceuticals. The recall, initiated in March 2026 and reported in early April, is classified as Class II due to a 'lack of assurance of sterility.' This classification indicates potential issues in validation, monitoring, or procedural discipline rather than confirmed contamination. The recall includes products such as Artificial Tears, Dry Eye Relief, Ultra Lubricating Eye Drops, and Redness Relief. The FDA's action may lead to voluntary returns from pharmacies, distributors, and retailers, and increased monitoring of affected batches. 
