More Than 2 Million Bottles of Eye Drops Recalled Over Potential Contamination

The U.S. Food and Drug Administration on October 27, 2023, recalled more than 2 million bottles of over-the-counter eye drops sold nationwide. Officials said the recall involved multiple brands and formulations due to possible contamination or sterility failures that could cause eye infections leading to partial vision loss or blindness.

The U.S. Food and Drug Administration on October 27, 2023, warned consumers not to purchase or to immediately stop using 26 over-the-counter eye drop products due to potential contamination that could cause eye infections, partial vision loss, or blindness. The affected products, marketed under multiple brands including CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, and Velocity Pharma, were sold nationwide, officials said. The FDA said the recall followed findings of insanitary manufacturing conditions and positive bacterial test results from environmental sampling in critical production areas.

The recall involves more than 2 million bottles of eye drops across multiple brands and formulations, with one related 2026 recall later described as involving 2,530,182 bottles of prednisolone acetate ophthalmic suspension.

The FDA recommended that the manufacturer recall all lots of the affected products as of October 25, 2023, after investigators uncovered these production issues. CVS, Rite Aid, and Target were reported to be removing the recalled eye drops from store shelves and websites, while Leader, Rugby, and Velocity branded products might still be available and should not be purchased, according to the FDA. On October 30, 2023, the agency updated its warning to include Equate Hydration PF Lubricant Eye Drop 10 mL, sold by Walmart.

Another major recall in 2026 involved about 3.1 million bottles of various products made by K.C. Pharmaceuticals, Inc., due to a lack of assurance of sterility, according to FDA records. A separate recall by AvKARE covered more than 75,000 cases and over 1.8 million cartons of consumer-level dry eye drops, the FDA said.

Officials emphasized the heightened risk posed by ophthalmic products because they are intended to be sterile and are applied directly to the eyes, bypassing many of the body’s natural defenses. The FDA’s October 2023 recall followed a CDC investigation linking the Global Pharma artificial tears to infections caused by VIM-GES-CRPA, a drug-resistant strain of Pseudomonas aeruginosa. That recall notice reported 55 adverse event reports, including eye infections, permanent vision loss, and one death associated with a bloodstream infection.

UC Davis Health reported that recalled eye drops in 2023 were associated with four deaths, 14 cases of vision loss, and 80 infections. The K.C. Pharmaceuticals recall, classified as Class II by the FDA, indicated the potential for temporary or medically reversible health effects due to possible bacterial or microbial contamination. The AvKARE recall was also classified as Class II and was triggered by current good manufacturing practice (cGMP) deviations identified during an FDA audit.

The FDA advised consumers to discard the recalled products properly, recommending disposal in sealed bags, and to seek medical care immediately if they experienced any signs or symptoms of eye infection. Consumers and health professionals were urged to report adverse events through the FDA’s MedWatch program. AvKARE instructed distributors to report existing inventory via fax or email as part of the recall response, indicating coordinated efforts across supply chains.

The recalled products were distributed through retail channels including Walgreens, Kroger, CVS, Walmart, and others, according to FDA notices. The agency’s actions reflect ongoing regulatory oversight aimed at preventing infections that could lead to serious eye health consequences. The FDA continues to monitor the situation and update its guidance as additional information becomes available.