Drug recall D-0716-2026
Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Reason for recall
Lack of Assurance of Sterility
Lots and codes
Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.
Recall details
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
- Quantity
- 6076306 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