Millions of Eye Drop Products Recalled Nationwide Due to Sterility Concerns

The California-based manufacturer K.C. Pharmaceuticals, Inc. voluntarily pulled the eye drops, which the FDA designated as a Class II recall on Tuesday.

Audrey Simons

Published: 4/3/2026, 3:12:27 PM EDT

Millions of Eye Drop Products Recalled Nationwide Due to Sterility Concerns — A woman applies eye drops in a stock photo. (Kim Kuperkova/Shutterstock)

More than 3.1 million eye drops have been recalled nationwide over concerns that the products may pose a potential contamination risk to consumers.

The California-based manufacturer K.C. Pharmaceuticals, Inc. voluntarily pulled the eye drops in early March due to a "lack of assurance of sterility," according to a notice from the U.S. Food and Drug Administration (FDA).

On Tuesday, the agency classified the recall as Class II, indicating the products "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

Several product formulations sold under dozens of store- and private-label brands are affected. Among them are 1,023,096 bottles of dry eye relief eye drops, 589,848 bottles of artificial tears sterile lubricant eye drops, 378,144 bottles of sterile eye drops original formula, 315,144 bottles of sterile eye drops redness lubricant, 303,216 bottles of eye drops advanced relief, 245,184 bottles of ultra lubricating eye drops, 182,424 bottles of sterile eye drops, and 74,016 bottles of sterile eye drops soothing tears.

The products were distributed at various retailers across the country, including CVS Pharmacy, Walgreens, Rite Aid, Harris Teeter, Publix, Circle K, and Discount Drug Mart. They were also distributed by companies such as Perrigo Direct, Gericare Pharmaceuticals Corp., Cardinal Health, McKesson Corp., and AmerisourceBergen.

All of the eye drops feature expiration dates in 2026. However, consumers can visit the FDA's website for a complete list of affected products.

Since eye drops and other ophthalmic products are applied directly to the eyes, they carry an increased risk to consumers because they bypass the body's natural defenses, the FDA notes on its website.

"Any drug used in the eyes must be sterile to reduce the risk of infection," the agency adds. "Preservatives play a crucial role in preventing microbial contamination, extending shelf life, and ensuring the safety of many eye drop products, especially eye drop products in multi-dose containers."

All eye drops sold in the United States must be registered with the FDA. The agency said it closely monitors eye drop products on the market through sampling and testing, as well as by reviewing any reported side effects.

The FDA said previous recalls of over-the-counter eye drop products have been linked to a variety of adverse health issues, including infections, partial loss of vision, and in severe cases blindness. It is unclear if any injuries have been reported in connection with the recent recall.

NTD reached out to K.C. Pharmaceuticals, Inc. for comment, but a response was not received by publication time.