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
Lack of Assurance of Sterility
| Recalling firm | Rohto-Mentholatum (Vietnam) Co., Ltd. |
|---|---|
| Reason | Lack of Assurance of Sterility |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Jul 29, 2026 |
| Initiated | Jul 14, 2026 |
| Region | N/A, Vietnam |
| Distribution | Nationwide within the United States |
| Quantity | 2910148 cartons |
| Code/Lot | 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.… |
| Type | Voluntary: Firm initiated |
| Recall number | D-0722-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0722-2026)
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