FDA recall D-0716-2026

Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · drug

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 for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2026-07-14
Report date: 2026-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ho Chi Minh, N/A, Vietnam

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0716-2026