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Medium risk Drugs & MedicationsClass II

Rohto Cooling Eye Drops Recall

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The

Updated July 14, 2026

Rohto Cooling Eye Drops Max Strength (0.4 FL OZ / 13 mL bottles) has been recalled because the manufacturer cannot confirm the product is sterile. Using non-sterile eye drops can cause infection or irritation.

Is the Rohto-Mentholatum (Vietnam) Co., Ltd. recalled? Yes. This product was recalled by FDA on July 14, 2026. Details below.

What is recalled

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90 0.2%), Sterile, 0.4 FL OZ (13 mL) bottles. UPC 310742011012, NDC 10742-8158-1. Distributed by The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Am I affected

You're affected if you own a bottle of Rohto Cooling Eye Drops Max Strength (0.4 FL OZ / 13 mL) with UPC 310742011012 or NDC 10742-8158-1.

What to do right now

Stop using this eye drops product immediately. Do not put the drops in your eyes. Dispose of the bottle or return it to the retailer where you bought it. If you have used this product and experience eye redness, pain, discharge, or vision changes, contact your eye doctor.

The hazard

Lack of Assurance of Sterility

Brands affected

Rohto-Mentholatum (Vietnam) Co., Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0716-2026
Classification
Class II
Recalled
July 14, 2026
Read the official notice

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