AvKARE recalled over 75,000 cases of eye drops because they may not be sterile due to manufacturing deviations, which could pose a risk of eye infections.
Need a Texas Eye Drop Recall Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with an eye infection after using contaminated eye drops, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
AvKARE Eye Drops Recalled for Health Hazards
In May 2025, the U.S. health product distributor AvKARE announced a nationwide recall for more than 75,000 cases of eye drops and artificial tears due to possible health risks, including a lack of sterility.
How To Identify Recalled Eye Drops
AvKARE recalled the following eye drops and artificial tears products:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
Why Were AvKARE Eye Drops Recalled?
According to the FDA Class II Recall, the safety concerns include “cGMP deviations and a lack of assurance of sterility.” In other words, there were manufacturing problems that could result in the eye drops not being sterile, which might pose health risks.
AvKARE said it recalled the eye drops due to “manufacturing cGMP deviations identified during an audit by the FDA,” and explained:
“Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products. “
Were There Any Reports of Eye Infections?
No eye infections were reported. AvKARE did not describe what manufacturing deviations led to the recall, or the potential risks. The FDA issued a Class II recall, which is used when a product may cause “temporary or medically-reversible adverse health consequences.”
Eye Infections
The common symptoms of an eye infection depend on whether the infection is caused by a bacteria, fungus, virus, or parasite — but in general, the signs of an eye infection include:
- Eye discomfort
- Redness
- Itchiness
- Eyelid swelling
- Discharge from the eyes (fluid may be clear, yellow, white, or green)
- Crusty eyes in the morning
- Eyes are sensitive to light
- Blurry vision
- Vision loss
- Blindness
- Other symptoms (headache, fever, tiredness, etc.)
Other Eye Drop Recalls
The eye drop recall from AvKARE is just the latest in a string of recalls that have been announced since a deadly eye drop infection outbreak was linked to EzriCare Artificial Tears. That outbreak in 2023 infected at least 81 people in 18 states, including 4 people who died and 14 people who suffered blindness.
Other recalls for eye drops have also been announced in recent years, including Systane Eye Drops and dozens of other over-the-counter eye drops from major retailers.
Eye drop recalls have been announced by CVS, Target Up & Up, Walmart Equate, Rite Aid, Rugby, Leader, and others. These recalls highlight the safety issues surrounding eye drops, which are applied directly to the eyes, bypassing some of the body’s natural defenses, according to the FDA.
Need an Eye Drop Recall Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.