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Millions of Eye Drop Units Recalled Over Sterility and Manufacturing Failures
A major nationwide recall has been issued for several AvKARE-branded eye drop and gel products, following the discovery of significant manufacturing violations that could place users at risk of serious eye infections. The U.S. Food and Drug Administration (FDA) classified the situation as a Class II recall, indicating that the affected products may cause negative side effects. Concerns about the sterility of these ophthalmic products have prompted immediate action to protect public health.
At Parker Waichman LLP, we are actively investigating legal claims on behalf of patients who used these recalled products and experienced eye infections, vision loss, or related complications. We represent clients in all 50 states and are currently accepting cases nationwide. If you or someone you love suffered harm after using any of the affected AvKARE eye drops, we encourage you to speak with our legal team.
The recall affects more than 1.8 million cartons of over-the-counter eye care products distributed between May 26, 2023, and April 21, 2025. These products were manufactured by BRS Analytical Services and sold by AvKARE, a Tennessee-based healthcare distributor. The affected items include:
These eye products were widely used to treat dry eye symptoms such as burning, itching, irritation, and blurred vision. Many were used by patients daily and considered a safe remedy — until sterility concerns were brought to light.
The recall was initiated after an FDA inspection of the BRS Analytical Services manufacturing facility revealed violations of Current Good Manufacturing Practice (cGMP) regulations. These violations resulted in a lack of assurance that the products were sterile and safe for use.
The FDA’s audit showed that BRS Analytical Services had failed to maintain appropriate controls during the production of ophthalmic solutions, which require stringent sterility standards. A lack of proper controls increases the risk that these products may be contaminated with bacteria or other pathogens. Because these items are applied directly to the eyes, the consequences of using contaminated eye drops can be severe.
Although no adverse events have been reported to date, the FDA and AvKARE emphasized that the health risks cannot be ruled out. The potential danger, coupled with poor manufacturing oversight, led to the urgent removal of these products from the market.
Unsterile eye drops can introduce harmful microorganisms directly into the eyes, leading to infections that may require emergency treatment. Possible injuries and complications include:
Patients with compromised immune systems, previous eye surgeries, or chronic eye conditions may be at greater risk for severe complications. Some of these conditions can develop rapidly, so any unusual symptoms after using recalled eye drops should be addressed immediately by a medical professional.
Anyone who used one of the affected AvKARE eye products should stop using it immediately. It is important to retain the product packaging, take note of any symptoms, and seek medical evaluation if discomfort or visual disturbances occur.
Patients may also be eligible for a refund. AvKARE has instructed customers to submit a recall form, request a Return Authorization (RA), and return any affected products for a full credit, including shipping fees. However, a refund alone will not compensate for pain, suffering, medical bills, or long-term health impacts caused by defective medical products.
If you or a loved one used a recalled AvKARE eye drop product and experienced a serious eye infection, vision complications, or required medical treatment, you may be entitled to compensation. At Parker Waichman LLP, we are currently representing victims of defective pharmaceutical and medical products across the country.
We help clients recover damages for:
There are no upfront costs for you. We only collect legal fees if we win your case. Our legal team will handle all aspects of your claim, from medical record reviews to expert analysis and legal filings.
Our attorneys are here to protect your rights and hold negligent manufacturers accountable when their products harm consumers.
If you suffered an eye infection, vision changes, or other complications after using a recalled AvKARE eye product, do not wait to take legal action. Our national law firm is reviewing these cases now and offering free consultations to injured patients and their families.
Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. Call 1-800-YOUR-LAWYER (1-800-968-7529) today for your free consultation with a legal professional who can help you understand your rights and determine if you qualify for compensation.
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