Nearly 40,000 bottles of eye drops are being pulled from store shelves in the U.S. over concerns about possible contamination, according to the Food and Drug Administration (FDA). Prestige Brand Holdings, based in Tarrytown, New York, has voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops due to a “lack of assurance of sterility,” according to an FDA enforcement report. The FDA classified the action as a Class II recall, defined on the agency’s website as a moderate-risk situation “in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.” The recall specifically covers 15 ml bottles that carry the lot code 2552A and an expiration date of September 30, 2027. The eye drops were distributed by Medtech Products Inc, a Prestige Consumer Healthcare company. Clear Eyes Maximum Itchy Eye Relief is marketed in its packaging as a redness-relieving astringent/lubricating eye drop intended to relieve redness, itching, burning, and watery eyes. The product is sold at major retailers including Walmart, Target, Kroger, Giant Eagle, Meijer, Dollar General and Family Dollar stores. Consumers are advised to stop using the recalled eye drops and return them for a refund. Anyone concerned about the possible effects of the product should contact a pharmacist or healthcare provider. Recalls of eye drops and other related medicinal products have become relatively less common compared to the continuing food safety crisis in the US, which under the Trump administration has recently been grappling with one of the largest foodborne illness outbreaks in recorded history. Still, eye drop recalls happen. In 2023, for example, the FDA recalled EzriCare artificial tears after the eye drops were linked to an outbreak of Pseudomonas aeruginosa, a drug-resistant bacterial contamination. That outbreak may have caused one death and injuries to another 68 people. A small number of patients had to have the affected eye surgically removed.
