FDAHealthJuly 14, 2026
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), Distributed by: The Mentholatum Company, Orchard
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 14, 2026
Nationwide within the United States
What's affected?
- 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
- Brand
- ROHTO DIGI-EYE
- UPC
- 310742010602
- Lot code
- 4B1V
Additional details
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 65219 cartons.
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