Nearly 40,000 bottles of eye drops are being recalled across the country over concerns related to potential contamination, federal safety regulators said.
Prestige Brand Holdings, of Tarrytown, N.Y., issued the voluntarily recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops because of a “lack of assurance of sterility,” according to the U.S. Food and Drug Administration.
The recall, which began on July 29 and is continuing, involves 15-millimeter bottles with a lot code of 2552A and an expiration date of Sept. 30, 2027.
“Consumer safety is our No. 1 priority,” said Phil Terpolilli, a spokesman for the company, said in an email on Sunday.
He said one lot was recalled because of “a potential for contamination identified during the manufacturing process.”
Mr. Terpolilli did not elaborate on what type of contamination nor did the F.D.A.
“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,” he said.
Mr. Terpolilli added that no “serious adverse events have been reported to date” and no other products were included in the recall.
The eye drops were distributed by Medtech Products Inc., a Prestige Consumer Healthcare company, according to the F.D.A. notice.
The agency listed the recall as a Class II, which it described on its website as a “situation in which 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.”
The Clear Eyes Maximum Itchy Eye Relief brand is an “astringent/lubricant redness-reliever eye drop” that works to provide relief from redness, itching, burning and watery eyes, according to its packaging label.
The product is sold at major retailers, including Walmart and CVS.
Consumers should stop using the recalled product and return it to the store of purchase for a refund.
Mr. Terpolilli said consumers with questions about the product could reach out through the Clear Eyes website or call customer service at 800-443-4908 on weekdays.
Recalls of eye drops are not as common as food-related recalls, but they do happen.
In 2023, two brands of eye drops were pulled from shelves after health agencies said they were linked to a drug-resistant bacteria strain that had been found to have caused four deaths and serious health issues in several others.
Two other types of eyedrops were also recalled at the time as a result of a different kind of contamination risk.