Over-the-counter eye products recalled: See the list

Millions of cartons of eye drops and other eye products have been recalled nationwide due to manufacturing and quality issues. 

The company AvKARE issued the voluntary recall after issues were identified during an audit by the Food and Drug Administration (FDA). 

AvKARE eye drops recalled

By the numbers:

About 1.8 million cartons of eye drops were recalled, according to the FDA.

What we know:

Products subject to the recall include:

  • 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

The faulty drops were distributed between May 26, 2023 and April 21, 2025. You can see lot numbers and expiration dates here.

What we don't know:

The notices from the FDA and AvKARE, a healthcare distributor for pharmaceuticals and infection control products based in Tennessee, did not specify what the exact issue was, or the health hazards of using the eye products.

However, the FDA said the reason for the recall was due to a "lack of assurance of sterility."

AvKARE said "it is not possible to rule out patient risks resulting from the use of these products."

Consumers should stop using eye products ‘immediately’

What's next:

The company said that further use of the products should "immediately cease."

AvKARE said that consumers with the recalled products can contact the company for a full credit, including shipping costs of any returns.

"We regret any inconvenience that this may cause," they added. 

The backstory:

The recalled eye drops were intended to treat dry eye, which is a condition that occurs when your eyes don’t make enough tears to stay wet, or when your tears don’t work correctly. This can make your eyes feel uncomfortable, and in some cases it can also cause vision problems, according to the National Institutes of Health

Dry eye is common — it affects millions of Americans every year. The good news is that if you have dry eye, there are lots of things you can do to keep your eyes healthy and stay comfortable.

Dry eye symptoms can include a scratchy feeling, like there’s something in your eye, stinging or burning feelings in your eye, red eyes, sensitivity to light and blurry vision.

Allergy season worse in 2025, experts say

Dig deeper:

The recall comes at a time when more people are using eye drops, as allergy season can cause worsening eye symptoms. 

Health experts say that allergy season is becoming more severe – and it has a lot to do with shifting environmental conditions. 

RELATED: Why allergy season feels worse in 2025 and what you can do about it

Doctors and scientists say climate change is extending the length of growing seasons and altering natural rhythms in plants. As temperatures rise and winters become milder, pollinating plants bloom earlier and continue releasing pollen for longer periods.

"Climate change impacts allergy season because the consistent rhythm… is all off kilter," Frederic Bertley, president of the Center of Science and Industry, told Healthline. That means places that usually see pollen later in spring are now getting hit earlier.

By the numbers:

In late March, Atlanta recorded a pollen count of over 14,000 grains per cubic meter—classified as "extremely high" by the Atlanta Allergy and Asthma Center. More than 25% of adults and about 1 in 5 children in the US now experience seasonal allergies, according to the CDC.

The Source: The information for this story was provided by AvKARE and the FDA. Previous FOX Local reporting also contributed. This story was reported from Los Angeles. 

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