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Rohto Recalls 12 Million Eye Drop Bottles Over Sterility Concerns

other · 2026-07-31

Rohto-Mentholatum has initiated a voluntary recall of eight Cooling Eye Drop products, covering more than 12 million bottles distributed nationwide, as announced on July 14. The recall was prompted by sterility concerns, as reported by the Food and Drug Administration. The affected products were widely distributed across the United States. Consumers are advised to check their supplies and discontinue use of the recalled items. The company is working with the FDA to address the issue. This recall highlights ongoing regulatory scrutiny of over-the-counter eye care products.

Key facts

  • Rohto-Mentholatum initiated a voluntary recall on July 14.
  • The recall covers eight Cooling Eye Drop products.
  • More than 12 million bottles are affected.
  • The recall is due to sterility concerns.
  • The FDA reported the recall.
  • Products were distributed nationwide.
  • Consumers are advised to stop using recalled products.

Entities

Institutions

  • Rohto-Mentholatum
  • Food and Drug Administration

Locations

  • United States

Sources