FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rohto Cooling Eye Drops Optic Glow recalled for lack of sterility assurance
OTHERNationwide distribution
Rohto Cooling Eye Drops recalled for sterility concerns
Rohto Cooling Eye Drops Optic Glow may not meet sterility standards required for eye products. The manufacturer cannot confirm that certain batches were manufactured under proper sterile conditions. No injuries have been reported.
- Check the lot number and expiration date on your bottle against the FDA recall list.
- Stop using the product if it matches a recalled lot number.
- Consult your eye care provider if you have used this product and experience eye irritation or discomfort.
- Contact Mentholatum at the number on the package for disposal instructions or a refund.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
1,278,457 cartons
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Products
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0718-2026More 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 Max Strength recalled for lack of sterility assurance
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