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Class II · ModerateActive recall

Rohto

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in Vietnam
Brand nameROHTO
Generic nameNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80
Active ingredient(s)NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80
Distributed by / forThe Mentholatum Company, Orchard Park, NY 14127
NDC10742-8158-2
Show the full FDA record
Full product labelRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Recalling firmRohto-Mentholatum (Vietnam) Co., Ltd.
DistributionNationwide within the United States
Quantity499,673 cartons
Recall initiated2026-07-14
Report date2026-07-29
Recall completed—
Recall numberD-0717-2026
ClassificationClass II
FDA statusOngoing
Origin on fileHo Chi Minh N/A Vietnam

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.