The U.S. Food and Drug Administration (FDA) has announced the recall of Polyvinyl Alcohol Ophthalmic Solution 1.4% Moisturizing Lubricant Eye Drops, a product commonly used to treat dry eyes, a condition affecting millions of Americans. The recall, issued on December 18, 2024, involves eye drops distributed by Tennessee-based AvKARE and sold under various off-label brands.
The recall stems from a labeling error, although the FDA has not clarified the specific nature of the mistake. While the agency classified the recall as a Class III risk, indicating that it is unlikely to result in serious health consequences, consumers are still advised to avoid using the affected products.
Eye dryness has become increasingly prevalent in recent years, with the Cleveland Clinic estimating that over 20 million U.S. adults suffer from mild to moderate forms of the condition. Dry eye symptoms can be triggered by factors such as environmental conditions, fatigue, or exposure to wind or smoke. The recalled eye drops, often referred to as “artificial tears,” are commonly used to alleviate these symptoms.
The FDA has not disclosed the total number of bottles sold but confirmed that the 0.5 fluid-ounce (15-milliliter) bottles were distributed nationwide. The specific details of the recalled product are as follows:
National Drug Code (NDC): 50268-678-15
Lot Number: 0160
Expiration Date: April 26, 2026
The FDA’s notice of the recall has not indicated any immediate health risks, but the potential for eye safety or comfort concerns due to the labeling error remains. Consumers are urged to return the products or dispose of them appropriately.
This recall follows a similar action in 2023, when the FDA recalled over 25 brands of eye drops due to contamination risks that could lead to eye infections. The FDA continues to monitor the safety of over-the-counter eye products as concerns about their safety persist.
With dry eyes becoming a widespread issue, particularly among adults over 50, eye drops remain a popular solution for those seeking relief. The Cleveland Clinic reports that approximately 5 million Americans experience severe dry eye symptoms, while an additional 20 million suffer from milder forms of the condition.
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