K.C. Pharmaceuticals of Pomona, California, has voluntarily recalled more than 3.1 million bottles of over-the-counter eye drops after the Food and Drug Administration said it lacked “assurance of sterility” for the products. The FDA notice said the company began the recall — covering 3,111,072 bottles — in early March and classified the action as a Class II recall, a designation for products that can cause temporary or medically reversible health problems.
The recalled items were manufactured for a variety of brands and sold under names such as Dry Eye Relief Eye Drops, Artificial Tears Sterile Lubricant Eye Drops, Sterile Eye Drops and Ultra Lubricating Eye Drops. Retailers that carried the products include major chains CVS, Walgreens and Rite Aid. Bottle size for the affected lots is listed as 0.5 fl oz (15 mL).
The FDA list identifies the specific formulations under recall, including Sterile Eye Drops AC (tetrahydrozoline HCl 0.05% and zinc sulfate 0.25%), EYE DROPS Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), and Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), among others. The full recall notice names eight product formulations and concentrations, all packaged in the same 15 mL bottles.
So far there have been no reports of injuries tied to the recalled eye drops, the FDA said. Under the agency’s guidance, a Class II recall does not automatically require consumers to stop using a product; people may continue use unless the manufacturer or the FDA issues a contrary statement. The agency did not provide details about what prompted the sterility concerns, and K.C. Pharmaceuticals did not immediately respond to requests for comment from reporters.
Maintaining sterility is critical for ophthalmic products because contamination of eye drops can introduce harmful microorganisms into the eye and lead to infections or other complications. The FDA’s recall classification reflects the agency’s assessment that any adverse effects from these products are more likely to be temporary or medically reversible rather than life-threatening, but the notice underscores the need for manufacturers to demonstrate robust sterile manufacturing controls for multiuse eye-drop bottles.
The recall adds to a string of recent drug and device alerts as regulators increase scrutiny of manufacturing practices. Consumers and retailers typically learn of lot numbers and return instructions via the company or the FDA recall announcement; the current FDA notice provides product names and formulations but did not list specific lot numbers in the public summary. The agency and the manufacturer may update the recall with additional information as their investigation continues.