FDA recalls nearly 76,000 eye care products over major safety concerns: full list inside
In a shocking development, The U.S. Food and Drug Administration (FDA) has issued an urgent recall of nearly 76,000 cases of eye care products due to serious safety concerns. This in essence, affects many popular eye drops and artificial tears that were found to have manufacturing issues, potentially putting users at risk.
If you use eye drops or artificial tears, it's important to check if your product is on the list. Let's find out more...
The reason behind the recall
The recall followed an FDA audit, that revealed significant deviations from Current Good Manufacturing Practices (cGMP) at the manufacturing facility of BRS Analytical Service, LLC. These deviations mean that the products fall short of the required safety standards.
Not only that, the FDA found a lack of assurance of sterility, which means the products might be contaminated and unsafe for use in the eyes. The list also included drops for dry eyes, as the FDA found 'lack of assurance of sterility" in the products.
While the exact health risks from using these products is still being studied, the FDA classified this recall as Class II. This means that using these products could cause many health issues, and although serious harm is unlikely, the risk cannot be overlooked.
List of Recalled Eye Care Products
The recall covers five different ophthalmic solutions distributed nationwide between May 26, 2023, and April 21, 2025. The products have expiration dates ranging from April 2025 to March 2027. Here is the list of affected items:
NDC #50268-043-15 Artificial Tears Ophthalmic Solution
NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
NDC #50268-126-15 Lubricant Eye Drops Solution
NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
What should users do?
Stop using the product immediately
Check the lot number and expiration date on your product against the recall list available on AvKare's (a medical firm that first notified the recall) website or the FDA recall notice.
Once identified, return the product to AvKare for a full refund. To do this, you need to fill out a return form available on AvKare's website, and send it to receive a Return Authorization Form.
Consult your eye doctor if you experience any irritation, redness, pain, or vision problems after using the recalled products.
Where Were These Products Sold?
The recalled products were distributed across the United States through retail outlets, pharmacies, and online stores.
Exact names of stores was no disclosed.
Why is sterility important in eye products
Eye drops and artificial tears must be sterile because the eyes are extremely sensitive and vulnerable to infections. Contaminated eye products can cause serious eye infections, irritation, or even damage to vision, which can also be permanent and irreversible.
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