The US Food and Drug Administration (FDA) announced a Class II recall for 39,060 15mL-bottles of Clear Eyes Maximum Itchy Eye Relief distributed nationwide. Prestige Brands Holdings voluntarily initiated the ongoing recall due to lack of assurance of sterility and potential contamination. The recall was initiated on July 29 and classified as Class II by the FDA on August 14.

Specifically, the product affected by the recall was Clear Eyes Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile (NDC: 67172-999-01 UPC 6 78112 65920 3), that was distributed by Medtech Products Inc. of Prestige Consumer Healthcare Company, Tarrytown, New York. The recall number is D-0766-2026 and the affected lot is lot 2552A, with an expiration date of September 30, 2027.

The over-the-counter eye drop is marketed as an astringent lubricant/redness reliever eye drop that also relieves itching, burning, and watery eyes, as stated on the packaging.

According to the FDA, a Class II recall is issued when 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.