Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Max Strength (naphazoline Hydrochloride 0.03%, Polysorbate 90, 0.2%), Sterile 0.4 Fl Oz (13 Ml)
Rohto Cooling Eye Drops Max Strength Recall Summary Rohto Cooling Eye Drops Max Strength (0.4 FL OZ bottles) is being recalled nationwide because the manufacturer cannot guarantee the product is sterile. The product was made in Vietnam and distributed by The Mentholatum Company, with UPC 310742011012 and NDC 10742-8158-1. This is a Class II recall affecting consumers across all U.S. states and Washington, D.C.
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- 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
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/77811987-3c2b-4d76-94d9-61341a3f2435