FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops Max Strength recalled for sterility concerns
Rohto Cooling Eye Drops Max Strength (a nasal decongestant eye drop product) was distributed without assurance that all units met sterility standards. The product is used directly in the eye, where any contamination could pose a risk of infection. This recall affects specific lot numbers distributed nationwide.
- Check the lot number on your Rohto Cooling Eye Drops Max Strength twin pack against the list provided (3H1V through 6C2V with various expiration dates through 2029).
- Do not use the product if your lot number matches any on the recall list.
- Contact Mentholatum Company or your retailer for instructions on disposal or replacement.
- If you have used this product and experience eye redness, irritation, or discharge, contact your eye care provider.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
499,673 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0717-2026More Rohto-Mentholatum (Vietnam) Co., Ltd. recalls
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Cool Relief recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Digi Eye recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Dry Aid recalled for lack of sterility assurance
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Optic Glow recalled for lack of sterility assurance
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