Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, Tetrahydrozoline Hcl 0.05%), Sterile, 0.4 Fl Oz (13 Ml)
Rohto Cooling Eye Drops Digi Eye (0.4 FL OZ bottles) distributed by The Mentholatum Company is being recalled nationwide because the manufacturer cannot confirm the product is sterile. The eye drops were made in Vietnam and distributed across all U.S. states. This is a Class II recall, meaning use of the product could cause serious adverse health effects.
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
- 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/2698272a-e1b2-4a3c-8e04-ae0742dbda1c