Rohto-Mentholatum (Vietnam) Co., Ltd. recalls Rohto Cooling Eye Drops Max Strength (naphazoline hydrochlor
See all recalls from Rohto-Mentholatum (Vietnam) Co., Ltd. →Recalled 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
Hazard / Issue
Lack of Assurance of Sterility
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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.
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
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