Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Digi Eye
- Recalling company
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- 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
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 14, 2026
- Reported
- Jul 29, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 65219 cartons
- Lot / codes
- Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
- Company location
- Ho Chi Minh, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0719-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0719-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.