FDA Announces Recall of Over 3 Million Eye Drop Bottles Due to Safety Issues
Over 3.1 million bottles of over-the-counter eye drops have been recalled by K.C. Pharmaceuticals due to sterility concerns, as announced by the U.S. Food and Drug Administration this week. The recall, initiated on March 3, 2026, impacts eight different eye drop products sold at major retailers such as CVS, Walgreens, Rite Aid, Kroger, and Publix.
The FDA has cited a “lack of assurance of sterility” as the cause for the recall. This implies that the company cannot guarantee that its products were not contaminated during the production or packaging process. The recalled products include:
- Dry Eye Relief Eye Drops
- Sterile Eye Drops
- Advanced Relief Eye Drops
- Artificial Tears Sterile Lubricant Eye Drops
These products have expiration dates that range from April 30 to July 31, 2026.
Dr. Nicole Bajic, an ophthalmologist at the Cleveland Clinic, highlighted the gravity of the situation: “Whenever we talk about using eye drops for the ocular system, it’s really important that there’s no bacterial contamination because that can cause significant and sight-threatening infections.” While no injuries have been reported so far, the FDA has classified this as a Class II recall, indicating that the products could lead to temporary or medically reversible health issues.
Consumers are urged to visit the FDA website for a comprehensive list of affected products and return any recalled items to stores for refunds.
Source: NBC News