Drug recall D-0722-2026
Product
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Reason for recall
Lack of Assurance of Sterility
Lots and codes
Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.
Recall details
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
- Quantity
- 2910148 cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 14, 2026
Related products
- Rohto – drug information
- NDC 10742-8141 Rohto Cool Relief · Naphazoline Hydrochloride .12 mg/mL; Polysorbate 80 2 mg/mL · The Mentholatum Company