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Rohto-Mentholatum (Vietnam) Co.

8 recalls on record · Last recall: Jul 14, 2026

Read the history in context

Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious
0
Class II — Moderate
8
Class III — Low Risk
0

Categories

MEDICATION

Recall Timeline

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

Class IIFDAJul 14, 2026

Rohto-Mentholatum (Vietnam) Co. — Lack of Assurance of Sterility

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 Lack of Assurance of Sterility

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