Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Cool Relief (naphazoline Hydrochloride 0.012%, Polysorbate 80 0.2%), Sterile, 0.4 Fl Oz (13 Ml) Each
Rohto Cooling Eye Drops Cool Relief is being recalled nationwide because the manufacturer cannot guarantee the product is sterile. The recalled product is 0.4 FL OZ bottles distributed by The Mentholatum Company with UPC 310742010749. This recall affects consumers across all U.S. states who may have purchased this eye drop product.
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
- 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/a88ac520-9cd9-48af-acd1-dc672d34e088