Eye care products, including artificial tears and drops, are being recalled by their distributor.
The recall responds to deviations from good manufacturing practices discovered during a U.S. Food & Drug Administration (FDA) audit.
See a list of recalled products below.
Several eye care products, including artificial tears and gel drops, are being recalled due to a manufacturing error that may cause a “health hazard,” according to the U.S. Food and Drug Administration (FDA) and the goods’ distributor, AvKare.
The FDA discovered Current Good Manufacturing Practices (CGmP) deviations during an audit, which means production didn’t meet standard protocol. AvKare didn’t share exactly what the deviations were and said the products’ specific “health hazard” to consumers is unknown. However, such error “may lead to products of unacceptable quality,” the statement read, and therefore, “it is not possible to rule out patient risks.”
With that said, the statement urged consumers to respond to the recall if they believe they have impacted product.
Eye care product recall details
The eye drops subject to recall were prescription-grade and manufactured by BRS Analytical Service, LLC between May 26, 2023 and April 21, 2025. If you have any of the bottles on hand, you may have been given them by a healthcare provider. The names and National Drug Code (NDC) numbers are:
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)
A full list of lot codes and specific expiration dates can be found here.
What to do with recalled product
If you have recalled eye drops, AvKare’s instructions are to fill out its recall form with the quantity of affected products in your possession and fax the form to 931-292-6229 or send it via email to customerservice@avkare.com.
Once that step is complete, AvKare will send a Return Authorization Form to be sent back along with the recalled product in a container marked: “Ophthalmic RECALL.”
Recalled product should be returned to the following address:
R&S Northeast LLC
8407 Austin Tracy Rd
Fountain Run, KY 42133
“We will issue full credit, including shipping cost, for any returns,” AvKare’s statement concluded. “If you have any questions on this matter, please contact us. We regret any inconvenience that this may cause.”
Questions or concerns can be directed to the Director of Quality, Renee Malone, at rmalone@avkare.com and/or Customer Service Representative Crystal Oliver at coliver@avkare.com.
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