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CLASS II · ModerateFDA

Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Optic Glow

📅 Jul 14, 2026 · 📍 Nationwide
Recalling company
Rohto-Mentholatum (Vietnam) Co., Ltd.
Product
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
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
1,278,457 cartons
Lot / codes
Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.
Company location
Ho Chi Minh, N/A
Recall type
Voluntary: Firm initiated
Recall number
D-0718-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0718-2026 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.