Prestige Brand Holdings has initiated a voluntary recall of nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops following FDA notification of potential sterility issues. The company, based in Tarrytown, New York, is pulling the affected product from shelves across the United States due to a documented lack of assurance of sterility in the manufacturing process.
The recall encompasses 39,060 bottles in 0.5-fluid-ounce (15 millilitre) containers carrying lot code 2552A with an expiration date of 30 September 2027. According to reporting on the recall, Prestige Consumer Healthcare initiated the action on 29 July 2026, with the FDA formally classifying it as a Class II recall on 14 August 2026. The FDA assigned the recall number D-0766-2026 to track the action.
The FDA defines a Class II recall as a moderate-risk 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 affected bottles were distributed by Medtech Products Inc, a subsidiary of Prestige Consumer Healthcare, and shipped to retailers across the entire country.
What is the recalled product?
Clear Eyes Maximum Itchy Eye Relief is marketed as an astringent and lubricant redness-reliever formulated to address redness, itching, burning and watery eyes. The product is widely available at major retail chains including Walmart, Target, Kroger, Giant Eagle, Meijer, Dollar General and Family Dollar stores.
Why is sterility in eye drops a serious concern?
Sterility failures in eye drops have drawn heightened regulatory and public attention since 2023, when the FDA recalled EzriCare Artificial Tears following contamination with Pseudomonas aeruginosa, a drug-resistant bacterium. According to coverage of that outbreak, the contamination was associated with at least one death and injuries to 68 other people, with some patients requiring surgical removal of the affected eye. That incident underscored the particular vulnerability of the eye to serious infection when sterile conditions are compromised.
What should consumers do?
Consumers are advised to stop using the recalled eye drops immediately and return them to the retailer where they were purchased for a refund. Anyone who has used the product and is concerned about possible adverse effects is encouraged to contact a pharmacist or healthcare provider for guidance. The FDA and Prestige Consumer Healthcare are monitoring for any reports of illness or injury related to use of the recalled product.
Key Facts
- 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief (lot code 2552A, expiration 30 September 2027) are being recalled due to lack of assurance of sterility
- The recall was initiated by Prestige Consumer Healthcare on 29 July 2026 and formally classified by the FDA as Class II on 14 August 2026 (recall number D-0766-2026)
- The product is sold at major retailers nationwide including Walmart, Target, Kroger, Giant Eagle, Meijer, Dollar General and Family Dollar
- A 2023 recall of EzriCare Artificial Tears for bacterial contamination resulted in one death and 68 injuries, making sterility issues in eye drops a heightened public-health priority
- Consumers should discontinue use and return the product for a refund; those with health concerns should consult a pharmacist or healthcare provider
