Washington, D.C. — More than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief have been voluntarily recalled across the country after concerns were raised about the sterility of one production lot.
The recall covers 39,060 bottles of the over-the-counter eye drops, according to information reported from the U.S. Food and Drug Administration’s enforcement reporting. The affected product is identified as Lot 2552A.
The FDA listing describes the reason for the recall as a potential contamination concern, specifically citing a “lack of assurance of sterility.” The available information does not identify a specific contaminant responsible for the concern.
Which Clear Eyes Eye Drops Are Recalled?
The recall is limited to a single lot of Clear Eyes Maximum Itchy Eye Relief in 0.5-fluid-ounce (15 mL) dropper bottles.
Consumers who have the product should check the information printed on the bottle and packaging. The affected product can be identified by these details:
- Lot number: 2552A
- Expiration date: September 30, 2027
- NDC: 67172-999-01
- UPC: 6 78112 65920 3
- Product: Clear Eyes Maximum Itchy Eye Relief
- Size: 0.5 fl oz / 15 mL
The product’s labeling confirms that the 15 mL bottle is associated with NDC 67172-999-01 and that Prestige Brands Holdings is the listed labeler.
Why Was the Eye Drop Lot Recalled?
The central concern is sterility.
Because eye drops are applied directly to the eyes, manufacturers must maintain strict controls to prevent contamination. In this case, the FDA enforcement report described the issue as a lack of assurance of sterility, prompting the voluntary recall.
The recall was initiated by Prestige Brand Holdings of Tarrytown, New York, on July 29, according to the information provided in the FDA enforcement report. The FDA subsequently classified the recall as Class II on August 14.
A Class II recall generally applies when use of or exposure to a recalled product could cause temporary or medically reversible adverse health consequences, or when the likelihood of serious harm is considered remote.
No Injuries Reported From the Recalled Lot
At the time of the recall information, no injuries linked to the affected lot had been publicly reported.
That does not eliminate the importance of checking products already sitting in medicine cabinets. The affected Clear Eyes product is marketed for temporary relief associated with itchy, dry, burning and red eyes, making it a product many consumers may use without thinking about its manufacturing lot.
The current product labeling identifies Clear Eyes Maximum Itchy Eye Relief as an ophthalmic OTC product containing glycerin, naphazoline hydrochloride and zinc sulfate.
What Should Consumers Do Now?
Anyone who has Clear Eyes Maximum Itchy Eye Relief should check the lot number before using the product.
If the bottle is marked 2552A, consumers should treat it as part of the recalled lot and avoid using it until they have obtained appropriate guidance about the recall and disposal or replacement process.
Consumers should also avoid assuming that every Clear Eyes product is affected. The recall is limited to the identified lot, so checking the exact lot number is important.
The recall comes as eye-drop safety continues to receive attention because sterile manufacturing is especially important for products applied directly to the eyes.
For now, consumers who find Lot 2552A in their medicine cabinet should take the recall seriously and verify the product before using it.
Have you checked your medicine cabinet for the recalled Clear Eyes lot? Share your experience or thoughts in the comments below.
