Nationwide Recall Issued for Popular Clear Eyes Eye Drops

Nationwide Recall Issued for Popular Clear Eyes Eye Drops

2026-08-20 companies

Washington, Wednesday, 19 August 2026.
Prestige Brands has recalled over 39,000 bottles of Clear Eyes eye drops nationwide due to sterility concerns, risking temporary health issues despite no confirmed injuries reported.

Nationwide Recall Initiated by Prestige Brands

Prestige Brands Holdings has issued a voluntary recall affecting 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief drops across the United States [1][2]. The enforcement action was initiated on July 29, 2026, following internal quality control reviews [3][5]. The United States Food and Drug Administration (FDA) subsequently published an enforcement report on August 14, 2026, detailing the scope of the recall [1][4]. The affected products were distributed nationwide through major retail channels including Kroger, Drug Mart, Giant Eagle, and Meijer [3][4]. This recall underscores ongoing regulatory scrutiny regarding sterility assurance in over-the-counter ophthalmic products [1][2].

Regulatory Classification and Health Risks

The FDA has classified this event as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences [2][4]. The agency determined there is a lack of assurance of sterility, creating a potential risk for contamination and infection [1][3]. While the probability of serious adverse health consequences is considered remote, the risk remains significant enough to warrant removal from shelves [4][5]. As of August 19, 2026, no specific contaminating organism has been identified by regulators [5]. Furthermore, no confirmed reports of injury or infection linked to this specific lot have been released by the FDA [3][5].

Product Identification and Market Impact

Consumers can identify the recalled items by checking for Lot number 2552A and an expiration date of September 30, 2027 [2][4]. The specific National Drug Code (NDC) is 67172-999-01, and the Universal Product Code (UPC) is 6 78112 65920 3 [4][5]. Each bottle contains 15 mL of solution, totaling 585900 mL of product removed from the supply chain [3][7]. Retailer websites largely removed the listing by August 17, 2026, though availability varied by location [3]. Prestige Brands Holdings, based in Tarrytown, New York, markets this product under its consumer healthcare portfolio which includes brands like Dramamine and Breathe Right [2][7].

Individuals in possession of the affected eye drops are advised to cease use immediately to avoid potential infection [4][5]. Products can typically be returned to the place of purchase for a refund, though consumers should contact local stores to verify specific return policies [1][4]. Legal firms such as Dolman Law Group are monitoring the situation for potential product liability claims involving manufacturing defects or negligence [5]. While no class action lawsuit has been established as of August 19, 2026, consumers are advised to preserve packaging if injuries occur [5][6]. Ongoing monitoring by regulatory bodies will determine if the recall expands to other lots or products in the future [5].

Sources


Pharmaceutical Manufacturing FDA Recall