Prestige Consumer Healthcare Recalls 39,060 Bottles of Clear Eyes Over Sterility Concerns

Nearly 40,000 bottles of a popular eye drop brand are off the market after the FDA classified a sterility problem tied to potential contamination.

Prestige Consumer Healthcare, based in New York, voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief on July 29, according to an FDA enforcement notice. The company's Medtech Products division distributed the eye drops nationwide, according to NBC News.

The FDA's stated reason is blunt: "lack of assurance of sterility." The agency's notice adds that the recall is "due to potential contamination," as reported by CBS News. Neither the FDA notice nor Prestige has said how the contamination may have occurred, according to the Epoch Times.

What's Affected

The recall covers 0.5-fluid-ounce (15-milliliter) dropper bottles labeled with lot number 2552A and an expiration date of September 30, 2027. The product's National Drug Code is 67172-999-01, with UPC 6 78112 65920 3, according to wrnjradio and the FDA notice.

Clear Eyes Maximum Itchy Eye Relief is sold over the counter at major retailers nationwide, including CVS and Walmart. The FDA classified this as a Class II recall, meaning use of the product could cause temporary or medically reversible health problems, or in rare cases something more serious, though the probability of serious harm is considered remote under that classification.

No injuries have been reported from use of the affected bottles, according to NBC News.

Timeline

Prestige initiated the recall July 29. The FDA classified it as Class II on August 14. The agency posted the public recall notice on August 19, and coverage followed August 20 and 21. Roughly three weeks elapsed between the company's internal recall action and the FDA's public classification, and another five days before the notice went public. The FDA notice does not explain that gap, and neither CBS News, NBC News, nor the Epoch Times pressed the agency on it.

Prestige Consumer Healthcare has not responded to requests for comment from NBC News, CBS News, or the Epoch Times.

Context: This Isn't the First Eye Drop Scare

Eye drop recalls have become a recurring problem. The Epoch Times noted that K.C. Pharmaceuticals recalled more than 3 million bottles of eye drops under multiple brand names in March over sterility issues.

Further back, in 2023, the FDA told consumers to stop using more than two dozen over-the-counter eye drop products, including versions sold under CVS Health, Rite Aid, Target, Walmart, Velocity Pharma, and Rugby store brands, over infection and vision-loss risk. That same year, the CDC warned of a drug-resistant Pseudomonas aeruginosa outbreak tied to EzriCare and Delsam Pharma products, which caused documented infections and, in some cases, vision loss and death in prior CDC reporting.

The Clear Eyes recall has not been linked to any injuries or the drug-resistant bacteria outbreak from 2023. It's a separate, distinct action based on a sterility assurance failure rather than a confirmed contamination pathogen.

What Consumers Should Actually Do

None of the four reports reviewed specify what step the FDA or Prestige wants consumers to take, though the Epoch Times notes that recalled products can typically be returned to the place of purchase for a refund. Consumers holding a bottle with lot 2552A and the September 2027 expiration date should check it against the NDC and UPC codes listed in the FDA notice before continuing to use it.

Repeated recalls spanning a national pharmaceutical scare in 2023 and a 3-million-bottle recall this past March raise a question about why eye drop manufacturers continue to struggle with sterility control. The FDA's Class II classification signals it doesn't consider this incident on the scale of the 2023 Pseudomonas outbreak. But the pattern of manufacturing lapses in a product category where sterility isn't optional, since these drops go directly into the eye, warrants examination of whether current FDA inspection frequency for OTC drug manufacturers is catching problems before bottles reach store shelves rather than after. Neither the FDA notice nor Prestige has addressed that question publicly as of this writing.