The U.S. Food and Drug Administration (FDA) has flagged a voluntary recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief due to potential contamination risks, according to an enforcement report published on August 19.
The recall, initiated by Prestige Consumer Healthcare on July 29, affects 15-milliliter bottles of the over-the-counter eye drops, which were distributed nationwide. The recalled products bear a lot code of 2552A, an expiration date of September 30, 2027, and a National Drug Code (NDC) of 67172-999-01.
The FDA classified the recall as Class II, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote. The agency did not specify the nature of the contamination or provide instructions for consumers beyond returning the product to the place of purchase.
Recent Context on Eye Drop Recalls
This recall follows multiple recent FDA actions involving eye drop products. In March 2024, K.C. Pharmaceuticals recalled more than 3 million bottles of eye drops under various brand names due to sterility concerns. In late July 2024, Vietnam-based Rohto-Mentholatum Co., Ltd. recalled approximately 11 million packages of Rohto Cooling Eye Drops across multiple strengths, also citing a lack of sterility assurance.
The FDA has not disclosed how the Clear Eyes products may have been contaminated or whether any adverse health events have been reported in connection with the recalled batches. Consumers with questions about the recall are advised to contact Prestige Consumer Healthcare or their healthcare provider.