Rohto-mentholatum (vietnam) Co., Ltd.: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, Propylene Glycol 0.3%), Sterile, Twin Pack 0.34 Fl Oz (10 Ml) Each

Rohto Cooling Eye Drops Dry Aid twin packs (10 mL bottles) distributed nationwide by The Mentholatum Company are being recalled because the manufacturer cannot guarantee the product is sterile. The recall affects the specific product with UPC 310742011159 and NDC 10742-8162-2 made in Vietnam.

Recalling firm
Rohto-Mentholatum (Vietnam) Co., Ltd.
Product
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
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/858fd5fb-42c3-45cc-bdff-a34944c494c3