Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 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 ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL)
- Distributed by
The Mentholatum CompanyOrchard ParkNY 14127Made in Vietnam UPC 310742010862NDC 10742-8146-1
- Lot codes and dates
Lot #: 3H1VExp. Date 2026/073J1V3J2VExp. Date 2026/093K1VExp. Date 2026/104A1V4A2VExp. Date 2026/124B1V4B2VExp. Date 2027/014G1V4G2V4G3VExp. Date 2027/064I1V4I2V4I2VA Exp. Date 2027/084J1V4J2VExp. Date 2027/094K2V4K3V4K4V Exp. Date2027/105B1V5B2V5B3VExp. Date 2028/015D1VExp. Date 2028/035E1V5E2V5E3VExp. Date 2028/045H1VExp. Date 2028/075I1VExp. Date 2028/085J1V5J2VExp. Date 2028/095L1V5L1VA5L1VB5L1VC5L1VD5L2VExp. Date 2028/116A1V6A2VExp. Date 2028/126B1VExp. Date 2029/01 & Lot 6C1VExp. Date 2029/02
- Amount recalled
- 1.033,266 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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