Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops All-in-one (hypromellose 0.2%, Tetrahydrozoline Hcl 0.05%, Zinc Sulfate 0.25%), Sterile 0.4 Fl Oz (13 Ml)
Rohto Cooling Eye Drops ALL-IN-ONE (0.4 FL OZ bottles) distributed nationwide by The Mentholatum Company is being recalled because the manufacturer cannot guarantee the product is sterile. The affected product was made in Vietnam and has UPC 310742010862 and NDC 10742-8146-1. This is a Class II recall affecting all U.S. states and the District of Columbia.
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product
- Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
- 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/422b8a22-bc83-4add-8d00-defea2cb2c9b