FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Digi Eye recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops Digi Eye recalled for sterility concerns
Rohto Cooling Eye Drops Digi Eye may not meet sterility standards required for eye products. The affected lots were distributed nationwide. No injuries have been reported.
- Check if you have Rohto Cooling Eye Drops Digi Eye with lot numbers 4B1V, 4B1VA (expiration 2027/01), or 4J1V (expiration 2027/09).
- Stop using the product if you have an affected lot.
- Contact The Mentholatum Company or your pharmacist for instructions on safe disposal or replacement.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
65219 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0719-2026More 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 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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