A sweeping eye drop recall has sparked concern among U.S. consumers after 1.8 million cartons of common over-the-counter eye care products were pulled from shelves. The recall, issued by Tennessee-based pharmaceutical company AvKARE, follows an FDA inspection that found critical manufacturing issues. The affected products were distributed nationwide from May 2023 through April 2025 and include several brands of artificial tears, lubricating gels, and dry eye solutions that many people use daily.
Although no injuries have been reported
The FDA discovered a lack of sterility assurance in the manufacturing process. That poses a risk for contamination, which could lead to irritation, infection, or worse, especially in people with sensitive eyes or compromised immune systems. Because of this, the eye drop recall has been classified as a Class II health hazard, serious enough to warrant action but not considered life-threatening.
If you or someone in your household uses over-the-counter eye drops, now is the time to check your medicine cabinet and take appropriate steps.
What Triggered the Eye Drop Recall
The FDA audit revealed that several AvKARE products were produced under conditions that did not meet proper sterility standards. Since these eye drops and gels are applied directly to the eye, any lapse in sterility can introduce harmful bacteria or contaminants. Even without reported injuries, the potential for harm was enough to initiate the eye drop recall as a preventive measure.
Eye products require a sterile manufacturing environment because even minor contamination can cause serious eye infections. The FDA found that AvKARE’s manufacturing facility failed to meet current Good Manufacturing Practices (cGMP), raising concerns about the safety of all affected products.
In response, AvKARE issued a voluntary recall and is urging customers to return or dispose of the products immediately.
Full List of Recalled Products
AvKARE recalled five specific eye drop products distributed throughout the U.S. You can use the listed National Drug Code (NDC) numbers to identify if your eye care items are affected:
- Artificial Tears Ophthalmic Solution
- NDC# 50268-043-15
- Provides relief for dry, irritated eyes.
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- NDC# 50268-066-15
- A thicker gel used for severe dry eye symptoms.
- Carboxymethylcellulose Sodium Ophthalmic Solution
- NDC# 50268-068-15
- A liquid version for easier use throughout the day.
- Lubricant Eye Drops Solution
- NDC# 50268-126-15
- Offers general moisture and comfort for dry eyes.
- Polyvinyl Alcohol Ophthalmic Solution
- NDC# 50268-678-15
- Mimics natural tears to reduce irritation.
These items are commonly used by people who suffer from dry eyes due to aging, screen exposure, environmental conditions, or medical conditions like blepharitis. If you recognize any of these in your household, stop using them immediately.
What to Do if You Have a Recalled Product
Even if you’ve opened or partially used the product, AvKARE urges consumers to return it. If you’ve discarded the item already, they still encourage you to complete a eye drop recall form to support tracking and safety documentation. If you discover any of the affected products from the eye drop recall list, take the following steps:
- Stop using the eye drops immediately.
- Locate the NDC number on the box or bottle to confirm whether it’s part of the recall.
- Contact AvKARE at [email protected] or fax them at 931-292-6229 to arrange for a return or refund.
- Return the product to this address:
R&S Northeast LLC
8407 Austin Tracy Rd
Fountain Run, KY 42133
If you’ve experienced any symptoms, such as burning, redness, discharge, or changes in vision, after using one of these products, consult a healthcare provider immediately.
Understanding the Severity of a Class II Recall
A Class II recall means that using the product could cause temporary or medically reversible health issues. It does not imply an imminent risk of serious injury or death. However, when it comes to eye health, even temporary irritation or infection can be distressing and potentially damaging if left untreated.
This eye drop recall is a reminder that even non-prescription items require rigorous manufacturing standards. Consumers often assume over-the-counter products are low risk, but as this situation shows, quality control failures can happen. Eye drops are particularly sensitive due to their direct contact with mucous membranes and the potential for infection.
Stay Informed to Protect Your Health
To stay ahead of future recalls, check the FDA’s Recalls and Safety Alerts page regularly. You can also sign up for email notifications that will alert you to health-related recalls in real time.
If you or someone you know experiences a reaction to any health product, recalled or not, you can report it through the FDA’s MedWatch program. These reports help public health officials identify dangerous patterns and respond quickly.
Knowledge is your first line of defense
Keeping an eye on safety alerts ensures that your home remains free of potentially harmful products. The AvKARE eye drop recall affects products millions of Americans rely on to treat dry, tired, or irritated eyes. While no injuries have surfaced so far, the FDA’s findings reveal a troubling lack of sterility, making this a recall worth paying attention to.
The Bottom Line
If you use any of the recalled products, verify the NDC number, stop using the product, and follow the return process. Your eye health is too important to ignore possible contamination. For a full list of affected items and detailed instructions, visit AvKARE’s recall page. Taking a few moments now could save you from potential complications later. In matters of vision and health, prevention is always the best approach.
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