Optometric ManagementFDA Recalls Nearly 12M Cartons of Eye Drops

📋 Regulatory Action / Label Change

The FDA designated a Class II recall for multiple Rohto Cooling Eye Drop products distributed nationwide. The recall was initiated because sterility of the ophthalmic products could not be assured, affecting products marketed for redness, dryness, and eye-strain relief.

Professional Impact

• The recall affects 11,960,623 cartons of over-the-counter ophthalmic products distributed throughout the United States.
• FDA classified the action as a Class II recall, reflecting potential temporary or medically reversible adverse health consequences.
• Affected products include formulations marketed for redness relief, dryness, eye strain, and cosmetic eye whitening.
• Product expiration dates span from July 2025 through February 2029, potentially leaving recalled inventory in circulation.

Action Items

• Review inventory for affected Rohto eye-drop products and recalled lot numbers.
• Advise patients using recalled products to verify lot information.
• Monitor FDA recall communications for updates regarding affected inventory.
• Document and report suspected adverse events through appropriate channels.