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
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 | 6076306 cartons |
| Code/Lot | 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, 4… |
| Type | Voluntary: Firm initiated |
| Recall number | D-0716-2026 |
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-0716-2026)
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