Nearly 40,000 bottles of eye drops are being recalled across the United States over potential contamination concerns, according to the U.S. Food and Drug Administration (FDA).

Prestige Brand Holdings, based in Tarrytown, New York, is voluntarily recalling 39,060 bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops due to a "lack of assurance of sterility," according to an FDA enforcement report. The affected product is packaged in 15-milliliter bottles bearing the lot code 2552A and an expiration date of Sep. 30, 2027. The recalled drops were distributed by Medtech Products Inc., a Prestige Consumer Healthcare company. Consumers can check the lot code and expiration date printed on their bottles against the details in the FDA's public enforcement report, which tracks recalled products, lot information and recall classifications.

The FDA has classified the action as a Class II recall, which the agency describes 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." Under the FDA's three-tier recall framework, Class II occupies the middle ground between Class I — the most serious category, reserved for situations in which exposure may cause serious adverse health consequences or death — and Class III, which applies to products unlikely to cause adverse health consequences.

Sterility is a core requirement for ophthalmic products such as eye drops, because the eye is particularly vulnerable to infection. For that reason, regulators and manufacturers treat any lapse in sterility assurance seriously, even absent a confirmed contamination finding. Eye-drop safety has drawn heightened public attention in the United States since 2023, when artificial tears sold under the EzriCare and Delsam Pharma brand names were recalled after federal health officials linked them to a multistate outbreak of a drug-resistant Pseudomonas aeruginosa infection, which the CDC associated with reports of vision loss and deaths. That episode was followed by a series of additional eye-drop recalls spanning both over-the-counter and prescription products.

The announcement follows other recent eye-drop safety actions covered by FOX Business: nearly 12 million bottles of Rohto eye drops were recalled over sterility concerns, and millions of bottles of prescription eye drops were recalled nationwide over contamination concerns.

Clear Eyes is one of several consumer health brands in the Prestige portfolio, alongside Dramamine, Luden's and Anacin. Prestige Consumer Healthcare, the parent company, is publicly traded on the New York Stock Exchange. In June, the company completed its acquisition of the Breathe Right brand — known for its nasal strips — and other assets from Foundation Consumer Healthcare in a deal valued at about $1.05 billion.

FOX Business reached out to Prestige Brands for comment.

Source: Fox Business Markets