Nearly 40,000 bottles of eye drops are being pulled from store shelves across the US over concerns about potential 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 because of a “lack of assurance of sterility”, an FDA enforcement report states. 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 probability of serious adverse health consequences is remote”.

The recall specifically covers 15ml bottles carrying lot code 2552A and an expiration date of 30 September 2027. The eye drops were distributed by Medtech Products Inc, a Prestige Consumer Healthcare company.

Clear Eyes Maximum Itchy Eye Relief is marketed on its packaging as an astringent/lubricant redness-reliever eye drop intended to provide relief from 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 being advised to stop using the recalled eye drops and return them for a refund. Anyone concerned about possible effects from the product is encouraged to contact a pharmacist or healthcare provider.

Eye drop and other related medicinal product recalls have become relatively less common compared with the continuing food safety crisis in the US, which under the Trump administration has recently been grappling with one of the largest recorded foodborne illness outbreaks in the nation’s history. Still, eye drop recalls do happen.

In 2023, for instance, 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 resulted in one death and injuries to 68 other people.

A small number of those sickened had to have the affected eye surgically removed.