More than 75,000 cases of eye care products have been recalled across the United States due to concerns about product sterility, the U.S. Food and Drug Administration (FDA) announced.
On April 23, BRS Analytical Services, LLC—a pharmaceutical manufacturer—voluntarily recalled five types of eye care solutions, including artificial tears and lubricating eye drops. The recall affects products distributed by AvKARE, a nationwide pharmaceutical distributor.
What Products Were Recalled?
The five recalled products include:
- Artificial Tears Ophthalmic Solution
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution
- Lubricant Eye Drops Solution
- Polyvinyl Alcohol Ophthalmic Solution
These items were distributed nationwide from May 26, 2023, through April 21, 2025. Consumers can find full details, including lot numbers and expiration dates, on AvKARE’s official website.
Why the Recall Happened
The FDA launched the recall after an audit revealed problems in the way the products were made. Specifically, the manufacturer failed to follow Current Good Manufacturing Practices (cGMP)—rules that help ensure medicine is made safely and correctly.
These violations may result in products that don’t meet quality standards. The FDA also said there is no guarantee that the products are sterile, which is especially important for anything used in or around the eyes.
Is There a Health Risk?
The FDA has classified the recall as Class II, which means the products may cause temporary or medically reversible health problems. However, the chance of serious harm is considered low.
Still, using non-sterile eye products could lead to irritation, infection, or other eye issues. Anyone using these products is advised to stop immediately and contact a healthcare provider if they experience any problems.
What Should You Do?
Check your medicine cabinet for any of the listed products.
If you have one, stop using it and contact your pharmacy or the manufacturer for further instructions.
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