FDA recalls over 11 million Rohto eye drop cartons nationwide over sterility concerns

Millions of bottles of Rohto eye drops sold across the United States are being recalled after the US Food and Drug Administration (FDA) classified a nationwide recall involving several popular products because their sterility could not be assured. The recall, initiated voluntarily by Rohto-Mentholatum (Vietnam) Co., Ltd., affects more than 11 million cartons of Rohto Cooling Eye Drops distributed nationwide in the US.

According to the FDA, the affected products were recalled due to a "lack of assurance of sterility," a manufacturing issue that could pose a risk because eye drops are intended to be sterile. The recall was initiated on July 14, 2026, and the FDA designated it a Class II recall on July 23, 2026.

Which Rohto eye drops are affected?

The recall covers eight Rohto Cooling Eye Drops products sold in the United States:

• Rohto Cooling Eye Drops ALL-IN-ONE
  
• Rohto Cooling Eye Drops Max Strength
  
• Rohto Cooling Eye Drops Max Strength Twin Pack
  
• Rohto Cooling Eye Drops Optic Glow
  
• Rohto Cooling Eye Drops Digi Eye
  
• Rohto Cooling Eye Drops Dry Aid
  
• Rohto Cooling Eye Drops Dry Aid Twin Pack
  
• Rohto Cooling Eye Drops Cool Relief
  

The recalled products include numerous lot numbers with expiration dates ranging from July 2026 through February 2029. Not every bottle of these products is affected by the recall. The recall applies only to specific lot numbers. Consumers can find the lot number and expiration date printed on the product packaging to determine whether their eye drops are included.

More than 11 million cartons included

According to the FDA enforcement report, approximately 11,060,623 cartons are included in the recall, making it one of the larger eye-drop recalls in recent years. The largest recalled product is Rohto Cooling Eye Drops Max Strength, with more than 6 million cartons affected, followed by Rohto Cooling Eye Drops Cool Relief, with over 2.9 million cartons, and Rohto Cooling Eye Drops Optic Glow, with more than 1.2 million cartons.

What does a Class II recall mean?

The FDA classifies this action as a Class II recall, meaning the use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences, while the probability of serious health consequences is considered remote.

At the time of the FDA enforcement report, no company press release had been issued, and the recall remains ongoing as the affected products continue to be removed from distribution.