A major recall has been issued for over 75,000 cases of eye drop solutions sold nationwide after a safety concern was raised about the sterility of the products.
The recall affects several ophthalmic solutions and was voluntarily initiated by BRS Analytical Service, a pharmaceutical testing lab.
The recall was reported by AvKare, a company that manufactures and distributes medical and pharmaceutical products.
The recall follows an audit by the US Food and Drug Administration (FDA) that uncovered manufacturing violations related to Good Manufacturing Practices (cGMP), NBC News said.
These practices ensure that pharmaceutical products are produced under safe conditions to protect consumer health.
According to AvKare, these deviations in manufacturing could result in products of poor quality, and there is a potential risk to patients who use these products.
The FDA report specifically cited concerns about the lack of assurance that the recalled products were sterile.
Sterility is crucial for eye care products, as contamination can lead to serious eye infections or other health complications. The affected products are commonly used to relieve dry or irritated eyes.
The recall includes a variety of eye lubricants and ophthalmic solutions shipped between May 26, 2023, and April 21, 2025. If you have any of the following products, stop using them immediately:
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
A pharmaceutical distributor issued an urgent notice about a voluntary recall for five over-the-counter eye care products over concerns with sterility. https://t.co/hAo7jmXRw7
— First Coast News (@FCN2go) May 14, 2025
How to Return Recalled Eye Drops and Get a Refund
These products are commonly used to treat dry eyes, but they may not meet the required safety standards.
If you have any of the recalled eye drops, AvKare recommends filling out a Recall Form and sending it via email.
According to USA Today, after submitting the form, you will receive a Return Authorization Form from the company.
This form should be used to return the affected products to the following address:
R&S Northeast LLC
8407 Austin Tracy Rd
Fountain Run, KY 42133
Consumers will receive a full credit for the returned products, including shipping costs.
If you are experiencing dry, itchy, or irritated eyes, experts suggest several alternatives to help relieve symptoms.
Dr. Yuna Rapaport, a board-certified ophthalmologist, recommends using a warm compress over your eyes for 30 seconds each day to treat aqueous dry eye, also known as blepharitis.
Additionally, using a humidifier in your bedroom can help ease symptoms of evaporative dry eye.
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