Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL…
Rohto-Mentholatum (Vietnam) Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rohto-Mentholatum (Vietnam) Co., Ltd. · No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park · Ho Chi Minh
Is this the product you have?
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL)
- Distributed byThe Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
- Lot codes and dates
Lot #: 3H1VExp. Date2026/073J2VExp. Date 2026/094A1V4A1VAExp. Date 2026/124G1VExp. Date 2027/064I3VExp. Date 2027/085A1VExp. Date 2027/125B3VExp. Date2028/015G3VExp. Date 2028/065J1VExp. Date 2028/095L1VExp. Date 2028/116A1VExp. Date 2028/126B4VExp. Date 2029/016C2VExp. Date 2029/02
- Amount recalled
- 499,673 cartons
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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