Eye products recall: Artificial tears and drops pulled over safety worries

Several types of artificial tears and eye drops have been recalled across the United States due to safety concerns, according to AARP. The recall involves Av Kare brand eye products, which were found to have possible contamination tied to problems in the manufacturing process. While there have been no reports of illness so far, the U.S. Food and Drug Administration (FDA) has labeled this a Class II recall. This means the products could cause temporary or reversible health issues, though the exact risks are still uncertain.

The recall covers a range of eye lubricants made by BRS Analytical Services and distributed by Av KARE, including Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel, and Polyvinyl Alcohol Ophthalmic Solution. Consumers are being told to stop using these products right away and to check the full list of affected items, expiration dates, and product codes for their own safety. AARP notes that concerns about product quality led to this urgent recall, and the FDA is monitoring the situation closely.

USA Today reports that the recall was prompted after an audit by the FDA found irregularities in the manufacturing process. Av KARE, the distributor, was notified by BRS Analytical Services, the company responsible for making the products. The recall includes several over-the-counter eye care items that were distributed between May 26, 2023, and April 21, 2025.

USA TODAY mentions that the main reason for the recall is to prevent potential risks to patients, even though the specific health dangers are not yet fully known. The FDA has been informed about the recall, and both Av KARE and the FDA are advising consumers to stop using the affected products immediately. USA TODAY highlights that further details, such as lot numbers and expiration dates, are available through Av Kare's press release and the FDA’s official recall notice. This action is part of a broader effort to ensure that only safe and high-quality eye care products remain available for consumers.

Fast Company adds that the recall was initiated after the FDA found violations of manufacturing standards, known as cGMP (Current Good Manufacturing Practice), during an inspection at BRS Analytical Service. The FDA’s audit discovered a lack of assurance of sterility in the production of five different ophthalmic solutions, including artificial tears and eye drops.

Fast Company explains that the recall was classified as Class II by the FDA, meaning that using these products could lead to reversible health problems, but the chance of serious harm is considered remote. BRS Analytical Service voluntarily started the recall on April 23, and the FDA officially classified it on May 6. The recall underlines the importance of strict manufacturing controls for products that go directly into the eyes. Fast Company notes that the health hazard to users is still unknown, but the recall was necessary because the products may not meet the required safety and sterility standards.

Sources:

https://www.aarp.org/health/conditions-treatments/eye-drops-recall-may-2025.html

https://www.usatoday.com/story/money/2025/05/12/eye-drops-artificial-tears-ophthalmic-products-recall/83576821007/

https://www.fastcompany.com/91332704/eye-drop-recall-may-2025-full-product-list-unacceptable-quality