More than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops are being pulled from shelves nationwide after federal regulators flagged concerns about the sterility of one manufacturing lot. The U.S. Food and Drug Administration reported that 39,060 bottles sold across the country were voluntarily recalled, with the agency's enforcement report citing potential contamination as the reason for the action.
The recall traces back to July 29, when Prestige Brand Holdings, based in Tarrytown, New York, initiated the action, according to Local Memphis. The FDA classified it as a Class II recall on August 14, a designation that carries a remote probability of serious adverse health consequences, though the agency notes such exposure could still cause temporary or medically reversible harm. Medtech Products Inc. distributed the affected eye drops, which are marketed over the counter to relieve itchy, dry, burning and red eyes.
Only one lot is affected: lot 2552A, with an expiration date of September 30, 2027. Consumers are advised to check their bottle's lot number against that code, and the recalled product carries NDC number 67172-999-01 and UPC 6 78112 65920 3, sold in 0.5 fluid ounce (15 ml) dropper bottles. The FDA's enforcement report cited a lack of assurance of sterility in the affected lot but did not specify the substance responsible for the contamination. No injuries have been publicly reported in connection with the recalled lot.
A Federal Enforcement Number Tied to the Recall
The FDA officially designated this recall under federal enforcement recall number D-0766-2026, according to NTD. That kind of precise tracking number allows consumers and healthcare providers to verify the specific enforcement action on government registries rather than relying on secondhand reports. Prestige Consumer Healthcare, which operates Medtech Products Inc., describes itself as North America's largest independent supplier of over-the-counter health products, with a portfolio that also includes Dramamine, Breathe Right, and Monistat, per the outlet's reporting.
This is not the first time the Clear Eyes line has faced a manufacturing scare. Medtech Products dealt with a retail-level recall of Clear Eyes products back in July 2019, after a contract manufacturer cited quality assurance control failures tied to critical systems at a manufacturing facility, according to a release from the Defense Commissary Agency. Contract manufacturing vulnerabilities, in other words, have a way of resurfacing across different product lots years apart.
Part of a Wider Pattern of Eye Drop Recalls in 2026
The Clear Eyes recall lands amid a broader wave of ophthalmic product pulls this year. In July, more than 11 million cartons of Rohto Cooling Eye Drops were voluntarily recalled over sterility concerns, as reported by Eyedropsafety.org. Store-brand and generic eye care products sold at major retailers have also been swept into this year's pattern of sterility-related recalls.
Hoodline reported in Pomona firm's 3.1M bottle recall that California manufacturer K.C. Pharmaceuticals initiated a Class II recall in March covering more than 3.1 million bottles of private-label over-the-counter eye drops sold at CVS, Walgreens, and Kroger, also over lack of sterility assurance. Prescription products have not been immune either — Lupin Pharmaceuticals recalled 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension 1% in July over the presence of a foreign substance, according to a UC Davis clinical pharmacologist's analysis published by UC Davis Health.
Why Over-the-Counter Eye Drops Slip Through Without Pre-Market Review
Unlike prescription ophthalmic drugs, over-the-counter eye drops do not require prior FDA review or approval before reaching store shelves, the UC Davis analysis notes. That regulatory gap means post-market surveillance and voluntary recalls like this one function as a critical line of defense once a sterility problem surfaces in a finished product.
The stakes behind that gap are significant. Topically applied eye drops bypass the body's natural defenses, creating a direct pathway for severe ocular infections, the FDA has explained, and unsterile products carry the risk of partial vision loss or permanent blindness. Federal oversight tightened considerably after a 2023 outbreak of drug-resistant Pseudomonas aeruginosa linked to contaminated eye drops caused at least four deaths, 14 cases of vision loss, and more than 80 infections nationwide, according to reporting from Healthline.
Since 2022, federal health monitors have documented more than 300 eye drop products subject to FDA notices or recalls, while agency inspectors have issued warning letters to 36 eye drop distributors and 17 manufacturing facilities, per the same Eyedropsafety.org tracking. Against that backdrop, the Clear Eyes recall represents one more entry in a pattern regulators have been watching closely for years, even though no injuries have surfaced in connection with this particular lot.
