Clear Eyes Drops Recalled Across US Over Contamination Risk, FDA Says

Around 40,000 bottles of a popular eye drop brand were recalled due to a potential contamination problem, according to a report published by the Food and Drug Administration this week.

An enforcement report said Prestige Brand Holdings is voluntarily recalling 39,060 bottles of its Clear Eyes Maximum Itchy Eye Relief drops, citing a “lack of assurance of sterility” and that the action was taken “due to potential contamination.”

Although the notice did not say what actions consumers should take, recalled products can typically be returned to the place of purchase. The report also did not say how the eye drops were potentially contaminated.

The bottles, which are sold over the counter, were distributed across the United States, the notice said.

The FDA classified the recall as a Class II, meaning that the “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.”

According to the report, the recalled products are in 15-milliliter bottles with an expiration date of Sept. 30, 2027, with a lot code of 2552A. The product’s National Drug Code (NDC) is 67172-999-01.

The company recalled the Clear Eyes drops on July 29, and the FDA classified the recall on Aug. 14. The FDA posted the recall notice on Aug. 19.

The Clear Eyes recall comes after several recalls of eye drops due to contamination or sterility concerns. K.C. Pharmaceuticals in March recalled more than 3 million bottles of eye drops under different brand names due to sterility issues.

And in late July, around 11 million packages of eye drops were recalled across the United States over a lack of assurance over their sterility, the FDA said. Vietnam-based Rohto-Mentholatum Co., Ltd. recalled several lots of Rohto Cooling Eye Drops in different strengths.

In 2023, the FDA told consumers to stop using more than two dozen over-the-counter eye drop products because of a risk that they might cause an eye infection that could lead to vision loss. The drops were marketed under CVS Health, Leader, Rite Aid, Target, Walmart, Velocity Pharma, and the Rugby brands.

Also in 2023, the Centers for Disease Control and Prevention (CDC) warned of an outbreak of Pseudomonas aeruginosa, a form of drug-resistant bacteria, linked to the contamination of separate brands of eye drops and artificial tears. At the time, it warned consumers not to use EzriCare artificial tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Ointment.

Prestige Consumer Healthcare did not immediately respond to an Epoch Times request for comment on Thursday.