Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Optic Glow (naphazoline Hydrochloride 0.03%, Povidone 0.5%, Propylene Glycol 0.2%), Sterile, 0.4 Fl Oz (13 Ml)
Recall Summary Rohto Cooling Eye Drops Optic Glow (0.4 FL OZ bottles) is being recalled nationwide because the manufacturer cannot guarantee the product is sterile. The product was distributed by The Mentholatum Company and made in Vietnam, with UPC 310742010916. This is a Class II recall affecting consumers across all U.S. states.
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
- 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/434989ab-f5af-4700-addc-7c431f4b77cf