Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Max Strength (naphazoline Hydrochloride 0.03%, Polysorbate 80 0.2%), Sterile, Twin Pack, 0.4 Fl Oz (13 Ml)
Recall Summary Rohto Cooling Eye Drops Max Strength twin packs (0.4 FL OZ) distributed nationwide by The Mentholatum Company are being recalled because the manufacturer cannot guarantee the product is sterile. The affected product has UPC 310742011210 and NDC 10742-8158-2. 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 Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
- 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/b748245e-5d6c-475d-a100-2c8d1e9f3676