The U.S. Food and Drug Administration (FDA) has raised alarm bells by advising consumers to cease the use of 26 over-the-counter eye drop products due to the possibility of bacterial contamination. The FDA issued a drug safety alert on October 27, highlighting the risks associated with certain eye drop products, including the potential for eye infections, vision deterioration, and even blindness. These products are available under the branding of major retailers and various brand names, with some of the notable ones being CVS Health, Rite Aid, and Target Up&Up.
Specific eye drop products affected by this warning include CVS Health Lubricant Eye Drops, Rite Aid Lubricant Eye Drops, and Target Up&Up Dry Eye Relief Lubricant Eye Drops. A comprehensive list of the affected products can be found on the FDA’s website.
The FDA’s warning was prompted by an inspection of the manufacturing facilities involved in the production of these eye drops on October 25, 2023. During this inspection, FDA investigators discovered “insanitary conditions” and detected positive bacterial test results in “critical drug production areas.” Contaminated eye drops can pose a significant risk of causing eye infections and more severe health complications.
The FDA emphasized the importance of sterility for these products, stating, “These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”
Up to this point, there have been no reported adverse events, such as eye infections, associated with the use of these affected products. However, there is limited information available regarding the nature of the contamination and its origin. The FDA has not specified the particular bacterial strain responsible for the contamination.
Healthline reached out to CVS, one of the retailers whose products were impacted by the FDA’s alert. CVS promptly responded with the following statement: “Upon receiving notification by FDA, we’ve immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio. Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter.”