Optometric ManagementFDA Recalls More Than 39,000 Bottles of Eye Drops

📋 Regulatory Action / Label Change

The recall affects 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief distributed nationwide. Prestige Brands initiated the voluntary action because of a lack of assurance of sterility and potential contamination. The recall is limited to lot 2552A and was classified by the FDA as a Class II recall, indicating temporary or medically reversible health consequences are possible, while the probability of serious harm is considered remote.

Professional Impact

• Recall limited to lot 2552A with expiration date September 30, 2027.
• Concern involves potential contamination and sterility assurance, not product efficacy.
• Product is sold OTC for redness, itching, burning, and watery eyes.
• FDA classified the action as a Class II recall rather than the agency’s highest-risk category.

Action Items

• Verify lot numbers when patients report using the product.
• Monitor for ocular symptoms potentially associated with recalled product exposure.
• Review FDA recall updates if additional manufacturing lots are identified.