The Food and Drug Administration is urgently warning Americans to immediately stop using more than 20 different over-the-counter eye drops.
The federal agency announced the commonly purchased items may put users at an increased risk for eye infections that could result in vision loss or blindness. Consumers who have been using one of the 26 products are being urged to talk to seek medical care.
The flagged eye drops are from the brands CVS Health, Leader, Rugby, Rite Aid, Target Up&Up, and Velocity Pharma.
“Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” according to the Oct. 27 press release. “FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.”
The agency has not received reports of eye infections linked to the 26 eye drop products.
Retailers like CVS, Rite Aid, and Target have pulled the products but eyedrops from Leader, Rugby, and Velocity may still be available in some places.
Eye drops have been the subject of multiple government warnings in the last year.
The FDA issued a warning to consumers in August after two eye drop products were linked to bacterial contamination, fungal contamination, or dual contamination. Americans were urged to stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops although no known cases had been reported at the time. Dr. Berne agreed to a voluntary recall.
“FDA conducted sampling and testing based on these products’ intended use in the eyes, and due to the industry’s recent manufacturing issues with eye drops,” the agency said in a statement. “FDA’s testing showed the products were contaminated with microbes and were not sterile. Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for use.”
In September, the FDA sent a letter to eight companies to forewarn them not to make or market ophthalmic products without approval. The agency asked the company to respond within 15 days with their plans to correct any legal violations.
“When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” Jill Furman, the director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in a statement. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”
The Centers for Disease Control and Prevention reported in February that there was an outbreak of the bacteria Pseudomonas aeruginosa linked to EzriCare Artificial Tears. At least 81 people contracted infections and one person died, per NPR. The manufacturer, Global Pharma, recalled the product.
