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FDA · Drugs ·

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%) recall

Rohto-Mentholatum (Vietnam) Co., Ltd. recalled Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%) on July 29, 2026 because of lack of Assurance of Sterility. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility

What's recalled

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

Quantity: 499,673 cartons

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0717-2026
Source
U.S. Food and Drug Administration

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