Thousands of eye care products have been pulled from shelves due to concerns about sterility. Here’s what you need to know to stay safe.
Over 75,000 cases of eye drops and artificial tears recalled across the U.S. due to sterility concerns, FDA reports.
Massive Recall of Eye Care Products Across the U.S.
More than 75,000 cases of eye care products have been recalled across the United States. The recall was announced due to concerns about product sterility and manufacturing practices.
Who Issued the Recall?
On April 23, BRS Analytical Service, LLC, the pharmaceutical lab responsible for the products, voluntarily recalled five different eye care solutions. The recall was supported by distributor AvKARE and the Food and Drug Administration (FDA).
Which Products Are Affected?
The recall includes the following products:
- Artificial Tears Ophthalmic Solution
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- Carboxymethylcellulose Sodium Ophthalmic Solution
- Lubricant Eye Drops Solution
- Polyvinyl Alcohol Ophthalmic Solution
These products were distributed nationwide between May 26, 2023, and April 21, 2025.The eye care solutions were distributed across the United States. The FDA and AvKARE did not provide details on specific retailers or states where the products were sold.The FDA found problems during an inspection of BRS Analytical Services. These issues are called cGMP deviations.cGMP stands for Current Good Manufacturing Practice. These are rules the FDA uses to make sure drugs are made safely and consistently. If a manufacturer doesn’t follow them, the products may not be safe.
AvKARE said the recalled eye care products might be of poor quality. It is not known if using the products is harmful, but risks cannot be ruled out. The FDA specifically said there was “a lack of assurance of sterility.”The FDA classified this recall as Class II on May 6. This means the recalled products might cause temporary or reversible health problems. The chance of serious harm is low, but not impossible.If you have any of these products, stop using them immediately. You can contact AvKARE or speak to a healthcare provider for guidance on alternatives.
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