POMONA, CALIFORNIA — K.C. Pharmaceuticals, a Pomona, California-based manufacturer, initiated a voluntary recall on March 31, 2026, covering 3,111,072 bottles of over-the-counter eye-drop products due to a lack of assurance of sterility, according to the Food and Drug Administration. The FDA classified the action as a Class II recall, a designation that applies to products that can cause temporary or medically reversible health problems.

The recall, which began in early March 2026, affects multiple eye-drop formulations sold in 0.5 fl oz (15 mL) bottles. The recalled products include Sterile Eye Drops AC, Advanced Relief Eye Drops, Dry Eye Relief Eye Drops, Ultra Lubricating Eye Drops, Sterile Eye Drops Original Formula, Sterile Eye Drops Redness Lubricant, Sterile Eye Drops Soothing Tears, and Artificial Tears Sterile Lubricant Eye Drops. The affected bottles have expiration dates ranging from April 30 to July 31, 2026.

The recalled products are sold at retailers including CVS, Walgreens and Rite Aid, as well as under store brand names including Kroger and H-E-B. No contamination has been detected in the recalled eye drops to date, and there have not been any reports of injuries associated with the products. Consumers may return recalled eye drops to the location where they were purchased for a refund, according to the FDA. Under a Class II recall, people can continue using their medication unless stated otherwise by the company, according to the FDA notice. The FDA also warned consumers to check their medicine cabinets and discard any potentially hazardous recalled eye-drop products.

Nonsterile eye drops can contain bacteria, fungi, spores or viruses that pose health risks. Dr. Nicole Bajic, a Cleveland Clinic ophthalmologist, said, "Whenever we talk about using eye drops for the ocular system, it's really important that there's no bacterial contamination because that can cause significant and sight-threatening infections." Infections from contaminated eye drops can cause yellow or green discharge and blurred vision. Bajic recommended that patients with worsening eye pain, vision, irritation or light sensitivity that does not improve with artificial tears or warm compresses see a health care provider immediately.

In a separate incident in 2023, 81 people developed rare antibiotic-resistant Pseudomonas aeruginosa infections after using contaminated eye drops. Four of those people died, four required surgical removal of an eye, and an additional 14 patients experienced vision loss as a result of the infections.

FDA regulators require products that need to be sterile to be manufactured in a sterile environment. Manufacturers must remove potential microorganisms from their products, test them, hold them in a holding period to check for microbial growth, and seal them meticulously. If contamination is detected in a production facility or if seals are defective, a manufacturer is obligated to recall the product. If a manufacturer does not issue a voluntary recall for a product that cannot be guaranteed sterile, the FDA will request or mandate a recall. Sterility issues are more common in over-the-counter eye drops than in prescription eye drops.