Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13…
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 90, 0.2%), Sterile 0.4 FL OZ (13 mL)
- Distributed byThe Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
- Lot codes and dates
Lot #: 3H2V3H3VExp. Date 2026/073J1V3J3V3J4V3J5VExp. Date 2026/093K1V3K2VExp. Date 2026/104A2VExp. Date 2026/124B1V4B2V4B3VExp. Date 2027/014F1V4F2V4F2V4F3V4F4VExp. Date 2027/054G2V4G3V4G4V4G5VExp. Date 2027/064H1VExp. Date 2027/074I1V4I2V4I4V4I5VExp. Date 2027/08
- Amount recalled
- 6076306 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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