FDA Issues Warning About 27 Eye Drop Products Possibly Linked to Eye Infections

The Food and Drug Administration (FDA) has issued a warning concerning 27 eye drop products, raising concerns about their sterility and potential risk of causing eye infections. Major retailers like CVS Health, Walmart, Target, and several others were included in this advisory. Of these, Leader (Cardinal Health) has initiated a recall in response to the FDA’s alert.

The 27 eye drop products, including popular brands, were flagged by the FDA due to manufacturing in an “insanitary” facility, with environmental sampling tests revealing the presence of bacteria. This lack of sterility poses a significant risk of causing eye infections and vision complications.

The eye drop products impacted under the warning include brands such as CVS Health, Target Up & Up, Walmart, Rite Aid, Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma. Cardinal Health has voluntarily recalled six eye drop products under the Leader brand after receiving reports of adverse events linked to these specific items.

The FDA strongly advises consumers to stop using these eye drops and discard them immediately. While the recalled products are being removed from shelves and online stores, the agency urges vigilance, specifically cautioning against purchasing Leader, Rugby, and Velocity eye drop products.

The FDA’s heightened scrutiny in these cases of non-sterile eye drop products stems from recent outbreaks and cases of bacterial contamination in eye drops. In particular, these warnings reflect the risk of bypassing the body’s natural defenses when applying drugs to the eyes, which poses a heightened concern for infections that could lead to severe consequences like partial vision loss or even blindness.

It’s crucial for users of these eye drops to cease their usage immediately and properly dispose of any at-home stocks. Although these warnings have raised concerns, major manufacturers and established eye drop brands adhere to strict quality control measures, ensuring sterility and safety in their products. Artificial tears, commonly prescribed and available in the market, are largely safe for use. These warnings serve as preventive measures to safeguard public health while assuring the safety of most eye drop products available in the market.

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