Thousands of Eye Drops Pulled Due to FDA Audit Findings
If you regularly use eye drops, now is the time to inspect your stock. A recent audit by the U.S. Food and Drug Administration (FDA) led to the recall of more than 76,000 cases of eye care products. These items failed to meet key safety and quality standards.
BRS Analytical Service, LLC initiated the recall after FDA inspectors discovered violations of current Good Manufacturing Practices (CGMP). Although no health incidents have been reported, the company chose to recall the products as a precautionary measure.
What Products Are Affected?
The recalled items include various artificial tears and lubricating solutions. Distributors first shipped these products between May 26, 2023, and April 21, 2025. Since their expiration dates run through March 2027, many customers may still be using them. 
Here’s a complete list of the recalled products:
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Artificial Tears Ophthalmic Solution
Drug Code: 50268-043-15 – 13,872 cases -
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Drug Code: 50268-066-15 – 1,610 cases
Drug Code: 50268-068-15 – 32,876 cases -
Lubricant Eye Drops (Polyethylene Glycol 400 / Propylene Glycol)
Drug Code: 50268-126-15 – 13,104 cases -
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Drug Code: 50268-678-15 – 14,333 cases
What Should You Do Next?
If you find any of these items in your home, stop using them right away. To request a refund, consumers should complete the official recall form and send it to AvKARE via fax or email. After receiving your form, the company will provide instructions for returning the product and securing a full refund, including shipping costs.
For more information, you can refer to the full recall notice on the FDA’s website.
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FDA’s Ongoing Oversight of Eye Care Products
The FDA has been closely monitoring eye care product safety in recent years. In fact, this latest recall adds to a growing list of similar actions:
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October 2023: The FDA warned customers about 26 over-the-counter eye drops from major retailers like CVS and Target. Those products carried a high risk of bacterial contamination, which could result in partial vision loss or blindness.
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September 2023: Officials sent warning letters to eight companies for selling unapproved eye treatments for glaucoma, pink eye, and cataracts. Several products contained silver, a substance that can cause long-term health problems.
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Earlier in 2023: The FDA linked EzriCare Artificial Tears to severe infections. Dozens of patients required hospitalization, and one person tragically died.
Final Thoughts
This large-scale eye drop recall in 2025 serves as a reminder to stay informed and cautious. Even when products seem safe, manufacturing flaws can still put your health at risk. Always check product recalls and stay updated on FDA alerts.
