Nearly 40,000 bottles of a popular over-the-counter eye drop product have been pulled from shelves nationwide after the manufacturer flagged a possible sterility issue, according to a U.S. Food and Drug Administration
enforcement report.
Prestige Consumer Healthcare Inc., operating through its subsidiary Medtech Products Inc., voluntarily initiated the recall on July 29, 2026, and the FDA classified the recall on Aug. 14. The report lists the recall as ongoing and notes that the affected bottles were shipped to retailers across the entire country. In total, 39,060 bottles are covered by the recall, and the FDA assigned it recall number D-0766-2026.
The recalled item is Clear Eyes Maximum Itchy Eye Relief, sold in 0.5-fluid-ounce dropper bottles and manufactured under sterile conditions. Bottles carrying lot code 2552A and set to expire Sept. 30, 2027, are the ones under recall. The product can be identified by NDC number 67172-999-01 and UPC 6 78112 65920 3.
The FDA report attributes the action to a "lack of assurance of sterility," adding that the recall stems from potential contamination of the product. Regulators designated the recall
Class II, a category the agency has previously described as covering situations where a product could cause temporary or reversible health problems, or where serious harm is unlikely but not impossible. Consumers who have the affected eye drops should stop using them immediately, since the contaminated drops could lead to infection.
Medtech Products Inc. operates as Prestige Consumer Healthcare company, and the parent firm describes itself as the largest independent seller of over-the-counter health products in North America. The company states on its website that it aims to build product lines that keep pace with changing consumer needs while maintaining quality across its offerings, which include brands such as Dramamine, Breathe Right nasal strips and Monistat.
This is not the only eye drop recall tied to sterility concerns this year. Earlier in August, Vietnam-based Rohto-Mentholatum Co., Ltd.
recalled more than 11.9 million cartons, containing roughly 12.4 million bottles, of its Rohto Cooling Eye Drops line after the FDA cited the same "lack of assurance of sterility" language. That recall, which the company initiated July 14 and the FDA classified July 23 as Class II, covered multiple product varieties including All-In-One, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief, with expiration dates spanning from July 2026 to February 2029. In all, the recall enforcement report lists 11,960,623 cartons of eye drops, which contain 12,460,649 bottles, as being under recall.
Anyone who purchased the recalled Clear Eyes product should discontinue use and dispose of or return the bottles, according to typical guidance from the FDA in such recalls.
