FDAFDA · Food and drugs·Recall number D-0719-2026
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
Published July 29, 2026 · Recall initiated: July 14, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ROHTO DIGI-EYE
- Manufacturer
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Distributor
- Nationwide within the United States
- UPC
- 310742010602
- Lot
- Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Vietnam
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