Over 500,000 Eye Drop Products Recalled Over Sterility Concerns — Here’s What To Know
on
Eye Drops Recalled Over Sanitization Concerns
More than 500,000 bottles of eye drops have been recalled nationwide over concerns that the products may not have been properly sanitized during manufacturing.
Sterling Pharmaceutical Services LLC, an Illinois-based pharmaceutical company, issued the recall on August 20, 2026. The affected eye drops were marketed under several brand names, including Walgreens, with the recall involving nine products and a total of 747,844 units, the U.S. Food and Drug Administration (FDA) reports.
“Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection,” the FDA wrote.
The FDA later determined the recall as Class II on September 21.
According to the FDA, this class of recall is described as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The FDA requires facilities that manufacture eye drops for the U.S. market to be registered with the agency. It also monitors these products after they reach the market through surveillance efforts, including product sampling, testing and tracking reported side effects.
The recall includes approximately 301,114 bottles of Walgreens Lubricant Eye Drops (0.5 fluid ounces), along with another 199,600 twin-packs of the product sold and distributed by Walgreens.
Also affected are about 12,864 packs of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops (0.5 fluid ounces) and 107,377 two-count packs distributed by AvKare.
The recall also covers approximately 11,083 bottles of Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5% (0.5 fluid ounces) and 47,616 bottles of Reliable-1 Laboratories Lubricating Tears (0.5 fluid ounces), both distributed by Reliable-1 Laboratories LLC.
Customers who may have purchased any of the recalled eye drops should stop using them immediately and contact their healthcare provider for guidance.
