Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ROHTO Redness Relief Recalled by The Mentholatum Co. Due to Lack of Assurance of Sterility: The Mentholatum Company...

Date: January 16, 2014
Company: The Mentholatum Co.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Mentholatum Co. directly.

Affected Products

ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Quantity: 59, 376 units Total (32,184 units held in stock, quarantined)

Why Was This Recalled?

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Mentholatum Co.

The Mentholatum Co. has 6 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report