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Medium risk Drugs & MedicationsClass II

Rohto Cooling Eye Drops Recall

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by

Updated July 14, 2026

Rohto Cooling Eye Drops Cool Relief has been recalled because the manufacturer cannot guarantee the product is sterile. Use of non-sterile eye drops can lead to eye infections.

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 Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), 0.4 fl oz (13 mL) bottles, UPC 310742010749, NDC 10742-8141-1, distributed by The Mentholatum Company, Orchard Park, NY 14127, made in Vietnam.

Am I affected

You are affected if you have a bottle of Rohto Cooling Eye Drops Cool Relief with UPC 310742010749 or NDC 10742-8141-1.

What to do right now

Stop using this product immediately. Do not apply it to your eyes. Contact The Mentholatum Company at the address listed on the package (Orchard Park, NY 14127) or check the FDA website for further instructions on returning the product.

The hazard

Lack of Assurance of Sterility

Brands affected

Rohto-Mentholatum (Vietnam) Co., Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0722-2026
Classification
Class II
Recalled
July 14, 2026
Read the official notice

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