A recall of nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief has been elevated to a Class II risk level by the Food and Drug Administration (FDA), signaling a potential danger to consumer health. This classification indicates that the use of the product could lead to temporary or medically reversible adverse health consequences, and carries a probability of serious adverse health consequences.
The recall, originally issued on July 29, involves 39,060 bottles of the over-the-counter eye drops. The reason for the recall is a "lack of assurance of sterility," which raises concerns about potential contamination with harmful particles, materials, or bacteria.
The affected product is sold in 15ml bottles and was distributed nationwide by Prestige Brands Holdings, based in New York. The specific lot number is 2552A, with an expiration date of September 30, 2027.
Consumers who have purchased these eye drops are advised to stop using them immediately. The FDA has not specified whether the drops have tested positive for contamination, the nature of any potential contaminants, or how the contamination may have occurred. To date, no illnesses or injuries have been confirmed in connection with this specific recall.
This action follows a similar recall issued last month for more than 12 million products from manufacturer Rohto, also due to a "lack of assurance of sterility." That recall affected six different Rohto over-the-counter eye drop products sold nationwide in various bottle sizes and cap colors, with best-before dates up to August 2028. The products included Rohto Cooling Eye Drops ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief, which are used to alleviate eye redness, inflammation, and other issues. It was unclear how many bottles were contained within the 12 million cartons recalled.
Notably, a significant eye drop recall occurred in 2023 involving products manufactured in India. Those eye drops were found to be contaminated with a deadly bacteria, leading to 81 reported illnesses, 18 cases of permanent blindness, and four deaths.