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 risk
Rohto Cooling Eye Drops Max Strength in certain lots may not be sterile. The manufacturer cannot assure that these drops meet sterility standards required for safe eye use. No injuries have been reported.
- Check the lot number and expiration date on your bottle against the recalled lots listed in the recall notice.
- Stop using the product if your lot number matches one of the recalled lots.
- Discard the recalled product or return it to where you purchased it.
- Contact your eye care provider if you have used this product and experience eye irritation or infection.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
6076306 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 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0716-2026More Rohto-Mentholatum (Vietnam) Co., Ltd. recalls
- 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 Max Strength 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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