FDA issues urgent recall for eye drops affecting up to 75,000 cases, leaving Americans scrambling for safe alternatives.
At a Glance
- The FDA has recalled multiple over-the-counter AvKARE eye drops due to manufacturing defects that could compromise safety
- Products shipped between May 26, 2023, and April 21, 2025 are affected, including various eye solutions and gels
- Consumers should immediately stop using these products and can receive full credit for returns
- A separate recall by Alcon Laboratories affects certain Systane products due to potential fungal contamination
- The manufacturing issues were discovered during an FDA audit that found violations of Good Manufacturing Practice regulations
Manufacturing Defects Prompt Widespread Recall
The Food and Drug Administration has announced an urgent recall of several over-the-counter eye drop products distributed by AvKARE after serious safety concerns were identified. The recall affects approximately 75,000 cases of eye care products, including Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. These products are commonly used by Americans seeking relief from dry and irritated eyes.
The recall was triggered after an FDA audit at BRS Analytical Services LLC, the manufacturer of the products, revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations. The specific nature of the “health hazard” has not been fully detailed, but officials have emphasized the potential risks are serious enough to warrant immediate action.
Scope and Timeline of the Recall
The affected products were shipped over a nearly two-year period between May 26, 2023, and April 21, 2025. The extensive timeframe has raised concerns about how many Americans may have been using potentially compromised eye care products. The FDA and AvKARE are working to notify consumers and retailers about the recall, emphasizing that continued use of these products could pose health risks that cannot be definitively ruled out.
Consumers who have purchased any of the recalled products are being advised to immediately discontinue use. AvKARE has committed to issuing full credit, including shipping costs, for all returns. The company has established a specific process for returns, requiring consumers to complete a recall form and send affected products to R&S Northeast LLC in Fountain Run, Kentucky.
Related Recall and Consumer Safety Measures
This recall follows a separate but related action by Alcon Laboratories on December 23, 2024, which pulled certain Systane products from the market due to potential fungal contamination. These successive recalls have heightened awareness about the safety of over-the-counter eye care products, prompting many Americans to scrutinize their medicine cabinets for potentially dangerous items.
The FDA classifies recalls into three categories based on risk level: Class I (high risk), Class II (moderate risk), and Class III (low risk). While the classification of this particular recall has not been explicitly stated, the urgent nature of the communication suggests significant concerns. The FDA has posted detailed recall information on its website and is collaborating with retailers to ensure all affected products are promptly removed from store shelves.
Alternative Solutions for Consumers
For Americans who rely on these products for eye care, medical experts have suggested several alternatives. Dr. Yuna Rapoport recommends increasing bedroom humidity to help with evaporative dry eye conditions. Other options include using warm compresses and specialized cleansing products that haven’t been affected by the recall. Consumers with concerns about their eye health should consult with healthcare professionals before switching to alternative products.
For specific questions or concerns about the recalled products, consumers can contact Renee Malone, Director of Quality, or Crystal Oliver, Customer Service Representative at AvKARE through the contact information provided in the recall notice. The company has established dedicated channels to address consumer concerns and facilitate the return process as efficiently as possible.
