Over 1.8 million cartons of eye drops have been urgently recalled after an FDA audit raised concerns over their sterility.
In a significant precautionary recall, AvKARE is pulling numerous eye care products off the shelves to prevent potential severe eye infections and vision loss, Daily Mail reported.
Distributors have shipped the eye drops—intended to alleviate symptoms of dry eyes such as irritation and blurred vision—nationwide from May 26, 2023, to April 21, 2025. These products include brands like Artificial Tears, Carboxymethylcellulose Sodium in both gel and solution forms, Lubricant Eye Drops, and Polyvinyl Alcohol Ophthalmic Solution.
AvKARE, a company based in Pulaski, Tennessee, initiated the recall after potential sterility issues caused by manufacturing defects were uncovered. This recall is classified as Class II by the FDA, suggesting that while the health risks are potentially serious, the probability of severe consequences is low.
The lack of guaranteed sterility may result in product contamination, posing significant risks to users. The FDA and AvKARE have flagged concerns that the affected products might not meet quality standards necessary for safe use.
BRS Analytical Service, LLC, an independent laboratory, played a crucial role in identifying these sterility concerns, prompting the recall.
After discovering the issue, AvKARE quickly advised consumers to stop using the recalled eye drops. The company also instructed retail outlets to promptly remove the affected products from their shelves and return them to the supplier for a full refund, including reimbursement for shipping costs.
AvKARE emphasized its concern for patient safety. "It is not possible to rule out patient risks resulting from use of these products," stated an official notice from the company, highlighting the indeterminable degree of risk involved.
The company also expressed regret over the inconvenience caused to consumers. "We regret any inconvenience that this may cause," the notice continued, reflecting their commitment to customer safety and satisfaction.
The timing of the recall coincides with the peak of allergy season, a period noted for an upsurge in eye drop sales due to heightened symptoms of dry eyes. This season typically leads to an increase in complaints of eye irritation, redness, and sensitivity to light, driving demand for ophthalmic solutions.
Despite the rigorous distribution and extensive use of these products over the past years, there have fortunately been no recorded health issues arising from the recalled eye drops up to this point.
The proactive recall aims to avert any potential health complications that could arise from continued use of the compromised products, safeguarding public health amidst rising seasonal demands.
AvKARE's decision to recall over 1.8 million cartons of eye drops is a significant preventive step to ensure consumer safety. The swift actions taken by both AvKARE and the FDA in addressing these concerns demonstrate a strong commitment to health standards and regulatory compliance.
We urge consumers to check if they have any of the mentioned products and stop using them immediately to avoid health risks. The company is providing full refunds to ensure customer trust and satisfaction remain intact amid the recall.
This incident serves as a reminder of the importance of stringent quality control and prompt response in the healthcare product industry, essentials for maintaining public trust and safety.
