The Recall Desk

FDA (Drugs) recall action 99440

Rohto-Mentholatum (Vietnam) Co., Ltd. recalled 8 products on 2026-07-29

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products
8
Announced
2026-07-29
Critical
0
Units
10,927,357

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

  • HighFDA (Drugs)··2026-07-29

    ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

    Rohto-Mentholatum is recalling ROHTO Cooling Eye Drops due to lack of assurance of sterility. The recall affects 499,673 cartons distributed nationwide in the U.S.

    Product
    Rohto 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
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2026-07-29

    FDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns

    The FDA is recalling ROHTO OPTIC GLOW sterile eye drops due to a lack of assurance of sterility. The recall affects 1,278,457 cartons distributed nationwide in the U.S.

    Product
    Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2026-07-29

    FDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap

    Rohto-Mentholatum is recalling 972,001 cartons of ROHTO DRY-AID sterile eye drops due to lack of assurance of sterility. The recall affects lots distributed nationwide in the U.S.

    Product
    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2026-07-29

    ROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap

    Rohto Digi-Eye cooling eye drops are recalled due to a lack of assurance of sterility. The recall affects 65,219 cartons distributed nationwide in the U.S.

    Product
    ROHTO DIGI-EYE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2026-07-29

    ROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling ROHTO Cooling Eye Drops due to a lack of assurance of sterility. The recall affects multiple lots distributed nationwide within the United States.

    Product
    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 Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2026-07-29

    Rohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.

    Product
    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2026-07-29

    ROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns

    The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.

    Product
    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
    Category
    Distribution
    0 states