New York, New York — Consumers who use Clear Eyes eye drops may want to check their medicine cabinets after the Food and Drug Administration reported a nationwide voluntary recall involving a specific product because of potential contamination concerns.
The recall affects Clear Eyes Maximum Itchy Eye Relief, an over-the-counter eye drop sold at major retailers across the country. The FDA says the concern involves the product’s sterility, although the manufacturer says the affected product has not been confirmed to be contaminated.
Which Clear Eyes Eye Drops Are Recalled?
According to the FDA notice, the recall involves 0.5-fluid-ounce bottles of Clear Eyes Maximum Itchy Eye Relief.
Consumers can identify the recalled product by checking the information printed on the packaging. The affected bottles are labeled:
- Lot number: 2552A
- Expiration date: September 30, 2027
- Recall number: D-0766-2026
The recall began on July 29 and remains ongoing.
The affected eye drops were distributed nationwide by Medtech Products, which is owned by Prestige Consumer Healthcare.
FDA Cites Sterility Concerns
The FDA classified the recall as Class II, a category used when exposure to a recalled product could potentially cause temporary or medically reversible health problems.
The specific reason listed in the FDA notice is “lack of assurance of sterility.”
Sterility is particularly important for products used directly in the eyes because contaminated ophthalmic products can potentially introduce harmful microorganisms to sensitive tissues.
However, consumers should not assume that every bottle from the affected lot is contaminated.
A spokesperson for Prestige Consumer Healthcare said the product was not confirmed to be contaminated when the company initiated the voluntary recall.
“Although the affected product was not confirmed to be contaminated, we initiated this voluntary recall out of an abundance of caution and our commitment to providing consumers with safe, high-quality products,” the spokesperson said in an email.
Eye Drops Sold at Major Retailers
The recalled Clear Eyes product has been sold over the counter nationwide, including through major retailers such as CVS and Walmart.
A total of 39,060 products are included in the recall, according to the information provided by the FDA.
Consumers who have purchased Clear Eyes Maximum Itchy Eye Relief may therefore want to inspect their bottle and packaging for the affected lot number before using it.
No Injuries Reported So Far
Despite the recall, officials say no injuries have been reported to date. The manufacturer also said that no other Clear Eyes eye drops are included in the recall.
That means consumers should carefully check the exact product, lot number and expiration date rather than assuming that all Clear Eyes products have been affected.
The recall remains active while the company and regulators address the sterility concern.
What Consumers Should Know
Anyone who has the recalled product should check the bottle for Lot 2552A and the September 30, 2027 expiration date.
Because the FDA lists the reason for the recall as a lack of assurance of sterility, consumers may want to avoid using a product that matches the recalled identification details until they have determined the appropriate next step.
The FDA’s Class II classification indicates that the potential consequences are generally considered temporary or medically reversible, although consumers should take recalls involving eye products seriously.
For now, the recall remains limited to the identified Clear Eyes Maximum Itchy Eye Relief lot, and no injuries have been reported.
Have you recently purchased Clear Eyes eye drops? Check your bottle and share this recall information with others who may have the affected product.
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