


Several types of eye care products that have been recalled by the U.S. Food and Drug Administration, such as eye lubricant gels and eye drops, have been shipped out to consumers up until last month — here’s what you should know.
The FDA announced last week that it has classified five different previously recalled eye care products, intended to relieve eye dryness, as a Class II recall. The agency labels recalled products as Class II when it believes the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The voluntary recall, which was initiated by the manufacturer, BRS Analytical Services, LLC, was announced by the FDA last month. The agency stated at the time that the products were being recalled due to deviations of cGMP, or Current Good Manufacturing Practices. The FDA also cited a “lack of assurance of sterility” as reason for the recall. More than 75,000 cases of products in total were affected.
The products in question were distributed by pharmaceutical healthcare distributor AvKARE. The company said in a statement that the “health hazard to the user is unknown.”
“[Current Good Manufacturing Practices] deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products,” the statement read.
AvKARE noted that the now-recalled products, which were available for distribution nationwide, were shipped between May 26, 2023, and up until April 21, 2025.
A majority of the products are not due to expire until later this year, or next year. Check out the product descriptions and the NDC, National Drug Code, below:
- 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
The FDA states on its website that it uses its cGMP as a way to ensure the quality of drug products. “The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have,” the agency states.

What should I do if I have a recalled eye care product in my home?
AvKARE said in its statement that further use of the recalled products “should immediately cease.” The company also advised its suppliers to remove the affected products from their inventory.
And if you’re dealing with eye dryness and wondering about the best course of action, the Mayo Clinic advises that there’s several tests that can help determine the cause of your dry eyes.
Your doctor may recommend a comprehensive eye exam that may include a complete history of your overall health to help determine the cause. You may also be given a test to measure the volume of your tears, a test to determine the quality of your tears, an examination of samples of your tears or a tear osmolarity test — which measures ” the composition of particles and water in your tears,” per the Mayo Clinic.
As always, you should share any concerns you may have about your eye health with your doctor.