Clear Eyes Eye Drops Recalled Nationwide Over Sterility Concerns

Key TakeawaysThe maker of Clear Eyes Maximum Itchy Eye Relief issued the nationwide recall Only lot 2552A with a Sept. 30, 2027, expiration date is affected; no illnesses reportedEarlier this year, a different maker recalled more than 3 million bottles of store-brand eye drops.TUESDAY, Aug. 25, 2026 (HealthDay News) — Nearly 40,000 bottles of a widely sold eye drop are being pulled from shelves nationwide because the maker cannot guarantee the product is sterile.Prestige Brands Holdings, of Tarrytown, New York, recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief, the U.S. Food and Drug Administration (FDA) said. The recall began July 29 and is still underway.Only one lot is involved: lot 2552A, with an expiration date of Sept. 30, 2027. The drops come in 0.5-ounce (15-milliliter) dropper bottles and were sold at major retailers including Walmart. The bottles carry National Drug Code 67172-999-01 and UPC 6 78112 65920 3.The reason the FDA listed is a "lack of assurance of sterility." A spokesman for the manufacturer, Phil Terpolilli, said the potential for contamination turned up during production, reports The New York Times.He did not say what kind of potential contamination was involved, and neither did the agency, according to The Times.The company acted "out of an abundance of caution," Terpolilli said, adding that the drops were never confirmed to be contaminated. He also said no serious side effects had been reported as of Aug. 23 and that no other Clear Eyes products are affected.Regulators classified the recall as Class II on Aug. 14. That is the middle of the FDA's three recall levels, used when a product may cause health problems that are temporary or reversible and when the chance of serious harm is considered remote.The drops are sold to relieve redness, itching, burning and watery eyes. Consumers who have the recalled lot should stop using it and return the bottle to the store where they bought it for a refund. This is the second large sterility-related eye drop recall this year. In March, K.C. Pharmaceuticals Inc., of Pomona, California, recalled more than 3 million bottles of artificial tears, lubricating drops and redness relievers sold under store labels including Walgreens, CVS Health, Kroger, Harris Teeter and Good Neighbor Pharmacy, according to FDA records. That recall covered eight products and was also rated Class II for a lack of assurance of sterility.Eye drop recalls are less common than food recalls but do happen, The Times reports.More informationVisit the U.S. Food and Drug Administration for more information about eye drop safety.SOURCES: The New York Times, Aug. 23, 2026; U.S. Food and Drug Administration, Aug. 14, 2026; U.S. Food and Drug Administration, March 31, 2026 .What This Means For YouCheck the lot code on any bottle of Clear Eyes Maximum Itchy Eye Relief in your medicine cabinet. If it reads 2552A, stop using it and take it back to the store for a refund..Sign up for our weekly HealthDay newsletter

Clear Eyes Eye Drops Recalled Nationwide Over Sterility Concerns

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