The FDA has recalled AvKARE eye drops and Alcon’s Systane product, raising safety concerns among consumers.
Key Insights
- The FDA recalled several eye drops due to potential manufacturing defects.
- The recall involves products distributed by AvKARE, identified by BRS Analytical Services LLC.
- Consumers should stop using and return the recalled products for full credit.
- Alcon Systane products face recall due to potential fungal contamination.
FDA Eye Drop Recall Details
The FDA has announced an urgent recall of AvKARE’s over-the-counter eye drops, including Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium products, and Polyvinyl Alcohol solutions. These products, meant to relieve dry and irritated eyes, were distributed from May 26, 2023, to April 21, 2025. The recall stems from manufacturing issues that may lead to products of unacceptable quality, posing potential risks to patients. Consumers are advised to discontinue use immediately.
R&S Northeast LLC in Fountain Run, KY, will handle the return of affected products. Consumers should fill out a recall form and send it to AvKare via email or fax to obtain a full credit, including shipping costs. “We will issue full credit including shipping cost for any returns. If you have any questions on this matter, please contact us. We regret any inconvenience that this may cause.” – The company.
Alcon Systane Product Recall
Alcon Laboratories has also recalled some Systane products due to potential fungal contamination. This previous recall by Alcon, announced on December 23, 2024, reflects ongoing concerns about eye product safety.
These incidents highlight the importance of rigorous manufacturing practices to prevent contamination and ensure the safety and efficacy of consumer medical products. The FDA ensures that such recalls are conducted swiftly and provides oversight while informing the public.
Precautionary Measures for Consumers
Experts recommend several alternatives for those with dry or irritated eyes, including using a warm compress, increasing humidity in living environments, as noted by Dr. Yuna Rapoport, “humidity in the bedroom is also helpful for evaporative dry eye”. Taking these precautions can help minimize dependence on potentially risky products.
Consumers concerned about similar product safety issues can check the FDA’s website for updates on recalls and safety alerts, which help protect public health by ensuring defective products are promptly removed from circulation.
