Reported Jul 29, 2026 · Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)…
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 · Ho Chi Minh, N/A · N/A
Is this the product you have?
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each
- Distributed byThe Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
- Lot codes and dates
Lot #: 3J1VExp. Date 2026/094A1VExp. Date 2026/124G1V4G2VExp. Date 2027/064I1VExp. Date 2027/084JIVExp. Date 2027/095A1VExp. Date 2027/125B1VExp. Date 2028/015F1VExp. Date 2028/055F1VAExp. Date 2028/055H1V & 5H1VAExp. Date 2028/075J1V5J1VAExp. Date 2028/095L1VExp. Date 2028/116B1VExp. Date 2029/01
- Amount recalled
- 2910148 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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