Drug recall D-0719-2026

Class II Ongoing reported Jul 29, 2026

Product

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

Reason for recall

Lack of Assurance of Sterility

Lots and codes

Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09

Recall details

Recalling firm
Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
Quantity
65219 cartons
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
July 14, 2026

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