The affected eye drops were voluntarily recalled over concerns they may not be sterile, according to the FDA
NEED TO KNOW
- More than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief have been recalled nationwide
- The voluntary recall comes amid potential contamination, with the FDA citing a “lack of assurance of sterility”
- Consumers are instructed to check for Lot 2552A and an expiration date of Sept. 30, 2027, on affected bottles
A Clear Eyes eye drop product has been recalled nationwide after its manufacturer raised concerns that the product may not be sterile and could potentially be contaminated, according to the Food and Drug Administration.
The recall affects Clear Eyes Maximum Itchy Eye Relief, which comes in 15 mL (0.5 fl oz) dropper bottles. A total of 39,060 bottles are affected, according to the FDA.
The recall was voluntarily initiated by Prestige Brands Holdings on July 29 and was classified by the FDA as a Class II recall on Aug. 14. The FDA says the recall is due to a “lack of assurance of sterility” because of “potential contamination.”
For consumers who may have the product at home, the affected bottles can be identified by Lot 2552A and an expiration date of Sept. 30, 2027, according to the FDA.
The product was distributed nationwide in the United States, according to the agency.
The FDA classifies a Class II recall as one involving a product that could cause “temporary or medically reversible health consequences,” or when the likelihood of serious health consequences is considered remote.
Clear Eyes Maximum Itchy Eye Relief is designed to soothe and moisturize the eyes, helping relieve irritation, burning and mild dryness, according to the product’s website. Its active ingredients are glycerin, naphazoline hydrochloride and zinc sulfate.
The product also contains benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride and sodium citrate as inactive ingredients.
The recall remains ongoing, according to the FDA.
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Prestige Consumer Healthcare, which owns several over-the-counter health care brands, including Dramamine, Chloraseptic and Summer’s Eve, is based in Tarrytown, N.Y., according to the company’s website.
PEOPLE has reached out to Prestige Consumer Healthcare for comment.
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