FDA announces nationwide recall of nearly 40,000 eye-drop bottles over potential contamination

Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops have been recalled across the United States because of a potential contamination problem, according to the US Food and Drug Administration (FDA).

According to an FDA enforcement report, Prestige Brands Holdings has initiated a voluntary recall of39,060 bottles of Clear Eyes Maximum Itchy Eye Reliefover concerns about the product’s sterility. The affected eye drops come in15 mL (0.5-fluid-ounce) dropper bottlesand are distributed by Medtech Products Inc., a Prestige Consumer Healthcare company.

The affected product carries NDC 67172-999-01 and UPC 6 78112 65920 3. Consumers can identify the recalled bottles by Lot 2552A and an expiration date of September 30, 2027.


The company initiated the recall on July 29, 2026, and the FDA classified it as a Class II recall on August 14. The recall remains ongoing.

A Class II recall is issued when exposure to or use of a violative product may cause temporary or medically reversible adverse health consequences, or when the likelihood of serious adverse health consequences is considered remote.

The FDA's enforcement report lists the reason for the recall as potential contamination and a lack of assurance of sterility. Because the product is a sterile eye drop, contamination can be particularly important because the medication is applied directly to the eye.

The recalled product was distributed nationwide, meaning affected bottles could have reached consumers across the United States.

The FDA has not issued a separate press release for the recall. The agency's enforcement report identifies Prestige Brands Holdings, based in Tarrytown, New York, as the recalling firm.

Consumers who have the recalled product should check the lot number and expiration date on their bottle and avoid using it until they have obtained further guidance.