Recall: D-0716-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-14Initiated

OngoingStatus

Rohto-Mentholatum (Vietnam) CoFirm

Product

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

Reason

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.