BRS Analytical Service has issued a voluntary recall of multiple ophthalmic products due to FDA-identified manufacturing concerns.
The products, distributed by AvKARE, may pose unknown patient risks related to manufacturing deviations.
Consumers are urged to immediately cease use and return affected items shipped between May 2023 and April 2025.
In an urgent notice to the public, BRS Analytical Service has announced a recall of several eye care products distributed to consumers across the U.S. The recall was triggered after the U.S. Food and Drug Administration identified current Good Manufacturing Practice (cGMP) deviations during a routine audit.
The FDA said the manufacturing irregularities could lead to products of substandard quality, and although no specific health hazard has been confirmed, potential patient risks cannot be ruled out.
Affected products and distribution timeline
The recall affects a range of over-the-counter eye treatments, including artificial tears, lubricant drops, and carboxymethylcellulose-based gels and solutions. Specifically, the following National Drug Codes (NDC) are involved:
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 0.5%
NDC 50268-126-15: Lubricant Eye Drops Solution
NDC 50268-678-15: Polyvinyl Alcohol Ophthalmic Solution
The affected lots were shipped between May 26, 2023, and April 21, 2025, with expiration dates extending into 2027. Consumers in possession of these products are advised to immediately discontinue use and inspect inventory for matching lot numbers.
What to do
Consumers and retailers are being asked to complete a “Quantity to Return” form and submit it via fax to 931-292-6229 or email to customerservice@avkare.com—even if no affected inventory is currently held. Once this form is submitted, a Return Authorization (RA) will be issued.
Recalled products must be sent to:
R&S Northeast LLC
8407 Austin Tracy Rd
Fountain Run, KY 42133
The return package should be clearly marked “Ophthalmic RECALL”, and a copy of the recall notice must be included. Full credit, including shipping costs, will be issued for returned items.