Recall

Rohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Recall

Lack of Assurance of Sterility Product details: 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

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Agency
FDA
Record ID
D-0719-2026
Canonical
https://claimwatch-mvp.vercel.app/item/rohto-mentholatum-vietnam-co-ltd-rohto-cooling-eye-drops-digi-eye-hypromellose-0-35-tetrah/

What happened?

Lack of Assurance of Sterility Product details: 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

Who may be affected?

Nationwide within the United States

What should consumers do?

Affected quantity: 65219 cartons

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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