A mass consumer alert has been made on over-the-counter eye care products because of a U.S. Food and Drug Administration (FDA) inspection, which indicated some extremely serious manufacturing violations. A voluntary recall has been issued by BRS Analytical Service across the country for five ophthalmic solutions because there was some uncertainty about whether or not the products met the FDA’s current good manufacturing practices (CGMP) standards.
While the manufacturer has received no reports of health complaints, the FDA warns that quality issues in sterile eye products can result in severe health effects, from infection to blindness. Consumers are thus being asked to stop using the affected products at once.
Five eye drop products recalled
The recall includes the following products, which were distributed between May 26, 2023, and April 21, 2025:
- 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)
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These products are typically used to treat dry, irritated, or inflamed eyes, conditions that can become more severe if treated with contaminated or substandard products. A full list of lot numbers is available here, and consumers are encouraged to check their medicine cabinets for any of the recalled items.
No adverse events — Yet
No reports of adverse events or injuries related to the recalled products have been made to date. Health professionals do note, however, that sterile eye solutions must be made under strict conditions to avoid microbial contamination. Even minor variations from production processes can lead to possibly serious health consequences, especially among vulnerable users such as those suffering from pre-existing eye conditions or compromised immune systems.
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Health risks cannot be avoided
Until it is ensured that these eye drops are adhering to minimum safety standards, the risk of harm in the form of eye infection, inflammation, or even permanent loss of vision remains. The FDA’s inspection of manufacturing did not detect some contaminants but found enough procedural errors to justify an emergency recall.
“Even in the absence of confirmed injuries, the lack of compliance with CGMP presents unacceptable risks to consumers,” the agency noted.
What consumers should do
Customers in possession of these products should immediately stop using them and safely discard any remaining bottles. If you’ve used any of these eye drops recently and experience symptoms such as eye redness, pain, blurred vision, or discharge, seek medical attention promptly.
Pharmacies and retailers have been notified of the recall and are requested to remove the recalled products from the shelves. For those who would like to be kept in the loop, register for recall alerts through the FDA or your local pharmacy.
Your eye health comes first
Customers are also cautioned to be careful when using over-the-counter eye care products and consult healthcare professionals for safe alternatives. The FDA will continue to monitor the situation and provide updates in the event that further action is needed.
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