Clear Eyes Eye Drops Recall 2026: Nearly 40,000 Bottles Recalled Over Sterility Concerns

Nearly 40,000 Clear Eyes Maximum Itchy Eye Relief bottles have been recalled nationwide over concerns about sterility. Learn how to identify the affected product and what consumers should do.

A nationwide recall has been issued for nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief after concerns were raised about the sterility of the over-the-counter eye drop product.

According to an enforcement report from the U.S. Food and Drug Administration, Prestige Consumer Healthcare Inc., through its subsidiary Medtech Products Inc., voluntarily initiated the recall on July 29, 2026. The FDA classified the recall on Aug. 14 and listed it as ongoing. The affected products were distributed to retailers nationwide.

The recall involves 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief. Consumers who have this particular lot should check the product information carefully and stop using it if it matches the recalled details.

Which Clear Eyes Eye Drops Are Recalled?

The recalled product is Clear Eyes Maximum Itchy Eye Relief, packaged in a 0.5-fluid-ounce dropper bottle.

Consumers should look for the following identifying information:

• Product: Clear Eyes Maximum Itchy Eye Relief
• Bottle size: 0.5 fluid ounces
• Lot code: 2552A
• Expiration date: Sept. 30, 2027
• NDC: 67172-999-01
• UPC: 6 78112 65920 3
• FDA recall number: D-0766-2026
• Quantity recalled: 39,060 bottles

Checking the lot number is especially important because a recall generally applies only to specifically identified products, lots, or expiration dates. The FDA advises consumers to compare the lot number on their medicine with the information provided in the recall notification.

Why Were the Clear Eyes Bottles Recalled?

The FDA report describes the reason for the recall as a “lack of assurance of sterility.” The agency's information indicates that the recall involves potential contamination.

Sterility is particularly important for products that are placed directly into the eyes. Unlike many medicines taken by mouth, ophthalmic products are applied to a sensitive part of the body, making manufacturing and quality controls especially important.

The FDA has previously explained that ophthalmic drug products can present a heightened risk because administration into the eye bypasses some of the body's natural defenses. Contaminated eye drops can potentially result in eye infections.

The FDA has classified the Clear Eyes recall as Class II. A Class II recall generally involves a situation in which use of the affected product could cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered remote.

That classification does not mean consumers should ignore the recall. Anyone who has the affected lot should avoid using it.

What Should Consumers Do?

If you have Clear Eyes Maximum Itchy Eye Relief at home, check the label before using it.

First, identify the lot code and expiration date. If the bottle is marked 2552A and expires Sept. 30, 2027, it matches the recalled product information.

Consumers with the affected product should stop using it. The FDA recommends checking recall information and following instructions provided by the manufacturer or regulator regarding disposal or return of recalled medicines.

If you have already used the recalled eye drops and develop unusual eye symptoms, consider contacting a healthcare professional promptly. Symptoms such as increasing redness, pain, swelling, discharge, light sensitivity, or changes in vision can require medical evaluation.

People with significant or sudden vision changes should seek urgent medical attention.

A Growing Focus on Eye Drop Safety

The Clear Eyes recall comes amid other eye drop recalls involving sterility concerns.

Earlier in August, another major eye drop recall involving Rohto products was reported after concerns about a lack of assurance of sterility. The FDA maintains recall databases and safety resources where consumers can check information about affected products.

These recalls highlight why consumers should pay attention to lot numbers rather than assuming every product under a particular brand is affected.

A recall can apply to a specific manufacturing lot, meaning other bottles of the same product may not necessarily be included.

How to Check for Future Drug Recalls

Consumers can monitor the FDA's drug recall information for updates. The agency explains that drug recalls may be initiated voluntarily by a manufacturer or may involve FDA oversight. The FDA also evaluates whether companies have taken appropriate steps to remove affected products from the market.

When checking a medicine, consumers should keep the original packaging when possible. The packaging typically contains useful information such as the product name, lot number, expiration date, and other identifying details.

If you are uncertain whether a product is affected, do not guess. Contact the manufacturer, pharmacist, or healthcare professional for clarification.

Bottom Line

The 2026 Clear Eyes eye drops recall affects 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief. The affected product is the 0.5-fluid-ounce bottle carrying lot 2552A and an expiration date of Sept. 30, 2027.

The recall was initiated because of concerns about the product's sterility, and the FDA classified it as a Class II recall.

Consumers who have the affected bottle should stop using it and consult official FDA or manufacturer guidance for next steps. Because eye drops are applied directly to the eye, sterility is an important safety consideration.

For the most current information, consumers should consult the FDA's official recall resources and verify the product's lot number before using it.

Source: U.S. Food and Drug Administration, Drug Recalls and recall guidance.

Disclaimer

This article is provided for informational purposes only and is not medical advice. Recall information can change as manufacturers and regulators provide updates. Consumers should verify the latest information through the FDA, the manufacturer, a pharmacist, or another qualified healthcare professional. If you experience serious eye symptoms or sudden changes in vision, seek appropriate medical care immediately.