Thousands of eye care products sold nationwide are being recalled: See the list of impacted items
BRS Analytical Service, LLC, is voluntarily recalling several of its eye drop products, according to a notice from pharmaceutical distributor AvKARE. While no specific health issues have been reported, the recall was prompted by 'manufacturing CGMP deviations' — meaning the products may not meet FDA quality standards. It's unclear whether these deviations pose a risk to users, so the company is recalling the products as a precaution.
The affected products include artificial tears and other lubricating eye solutions and were first shipped between May 26, 2023, and April 21, 2025. They have expiration dates that range from April 2025 to March 2027 — meaning it's possible these items are still being used by customers.
You can find specific information about what products are recalled on the FDA's website. Below are the products that are recalled:
Artificial Tears Ophthalmic Solution
Drug Code: 50268-043-15
13,872 cases recalled
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Drug Code: 50268-066-15
1,610 cases recalled
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Drug Code: 50268-068-15
32,876 cases recalled
Lubricant Eye Drops Solution (Polyethylene Glycol 400 / Propylene Glycol)
Drug Code: 50268-126-15
13,104 cases recalled
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Drug Code: 50268-678-15
14,333 cases recalled
If you find that you have one of these products, stop using it immediately. Consumers who want a refund can fill out a recall form and send it to AvKARE by fax or email, after which they'll receive instructions to return the product and get a full refund, including shipping.
This is not the first time in recent years that certain eye products have been the subject of scrutiny by the FDA. In October 2023, the FDA warned consumers about 26 over-the-counter eye care products, including eyedrops available at stores like CVS and Target, which came with the 'potential risk of eye infections that could result in partial vision loss or blindness.' At the time, the FDA discovered that the manufacturing facility had poor sanitation practices and that the products tested positive for bacteria, proving they weren't sterile as advertised.
And in September 2023, the FDA issued warning letters to eight companies for illegally marketing unapproved eye products that claim to treat conditions like pink eye, cataracts and glaucoma, some of which had sterility issues and/or contained silver, which can cause long-term health issues. The news came one month after the FDA warned consumers not to use Dr. Berne's and LightEyez MSM eye drops due to contamination risks and the use of an unapproved ingredient.
There was also an earlier wave of eye drop recalls in 2023, including one linked to EzriCare Artificial Tears that caused infections in dozens of people, resulting in hospitalizations, vision loss and at least one death, according to the FDA.
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