Drug recall D-0717-2026
Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Reason for recall
Lack of Assurance of Sterility
Lots and codes
Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Recall details
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
- Quantity
- 499,673 cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 14, 2026
Related products
- Rohto – drug information
- NDC 10742-8158 Rohto Max Strength · Naphazoline Hydrochloride .3 mg/mL; Polysorbate 80 2 mg/mL · The Mentholatum Company