FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops ALL-IN-ONE recalled for lack of sterility assurance
What this means
Rohto Cooling Eye Drops ALL-IN-ONE in specific lots does not meet sterility standards required for eye products. The issue was identified during manufacturing quality checks. Affected lots are distributed nationwide and are sold in pharmacies and retailers.
- Check the lot number and expiration date on your bottle against the FDA list
- Stop using the product if it matches an affected lot
- Dispose of the bottle safely or return it to the retailer
- Contact your eye care provider if you have experienced any eye irritation or discomfort
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
1.033,266 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0715-2026More Rohto-Mentholatum recalls
- 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
- FDA-Drug2026-07-29Rohto Cooling Eye Drops Max Strength 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 Digi Eye recalled for lack of sterility assurance
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