TemporaryFDAOngoing
Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.
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
Check the label for
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.
- Why
- Lack of Assurance of Sterility
- Distributed
- Nationwide within the United States
- Company
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222
Source: FDA record D-0722-2026 · retrieved 23 July 2026
Read the official notice