Rohto-Mentholatum (Vietnam) Co: multiple drugs
Rohto-Mentholatum recalls multiple Rohto Cooling Eye Drops over sterility concerns.
Stop using the recalled eye drops immediately. Check the product label for the affected brand names and UPC/NDC codes. Do not discard the product; contact Rohto-Mentholatum for instructions on return and refund.
Why it was recalled
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling multiple Rohto Cooling Eye Drops products — including ALL-IN-ONE, Cool Relief, Digi Eye, Dry Aid, Max Strength, and Optic Glow — due to a lack of assurance of sterility. The affected products were distributed nationwide.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | NDC / UPC |
|---|---|
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL) | UPC 310742011012, NDC 10742-8158-1 |
| Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)… | UPC 310742010749, NDC 10742-8141-1 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL) | UPC 310742011135, NDC 10742-8162-1 |
| Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile… | UPC 310742010916, NDC 10742-8160-1 |
| Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL… | UPC 310742010862, NDC 10742-8146-1 |
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL… | UPC 310742011210, NDC 10742-8158-2 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each | UPC 310742011159, NDC 10742-8162-2 |
| Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL) | UPC 310742010602, NDC 10742-8175-1 |
Official source
Editorial summary by Recall Canary · last updated 2026-07-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification