Product Recall  from Rohto-Menthalatum

This voluntary recall has been initiated by Rohto-Menthalatum for the following reasons:

• Potential concerns regarding affected products manufactured between July 2023 and March 2026.
• No known cases have arisen, but manufacturer is exercising caution around specific batches of products to ensure compliance with FDA regulatory requirements in the U.S. market.

Note: This recall should be carried out between the customer and McKesson Medical-Surgical Inc.

Rohto® Eye Drops

What is the issue?
Precautionary measures to alleviate concens from the U.S. Food and Drug Administration (FDA) regarding the of specific Rohto-Menthalatum product manufactured in Vietnam for the period between July, 2023, and March, 2026. 

What is the risk to health?
No known risks are published, the manufacturer is working with the U.S. Food and Drug Administration to ensure compliance with regulatory requirements in the U.S. market.

Status : Open

Please review the instructions below and submit your response(s) to Performance Health.

Return Instructions

IMPORTANT

1. Download the recall PDF here (Recall Notification of Rohto Eye Drops.pdf) for full details, affected product, and instructions.
2. If you plan to return the product fill out the return form on page 3 of the above PDF for the return.

Summary of PDF Steps:

1. CEASE distribution of all lots of all products subject to this recall.
2. REVIEW your inventory for the affected product code.
3. FILL OUT the above PDF return acknowledgment form (from the PDF) via fax to 614-652-9648 or email to MMSRecalls@McKesson.com regarding any affected product.

Where to find your Lot #