SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products, including products from CVS Health and Rite Aid, due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately. The eye drops are marketed by CVS Health, Rite Aid, Cardinal Health, along with Target's Up & Up brand and Velocity Pharma, according to the FDA statement.

It has also asked the manufacturer to recall all lots of the product after its investigators found insanitary conditions in the manufacturing facility.

The FDA recommended the manufacturer of these products recall all lots on Oct. 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 FDA also recommends consumers properly discard these products.

CVS, Rite Aid and Target are removing the products from their store shelves and websites, according to the FDA. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.

Currently, the FDA has not received any adverse event reports of eye infection associated with these products. The agency encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program.

As reported in VMAIL in September, the FDA warned eight companies, including CVS and Walgreens, against manufacturing or marketing unapproved eye products.