Rohto-Mentholatum: Multiple Rohto Cooling Eye Drops
Rohto Cooling Eye Drops recalled over sterility concerns; multiple formulations affected.
Stop using the recalled Rohto Cooling Eye Drops immediately. Return the product to the place of purchase for a refund, or contact Rohto-Mentholatum for instructions on how to receive a refund.
Why it was recalled
Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling multiple Rohto Cooling Eye Drops products due to a lack of assurance of sterility. The affected products include ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid, and Cool Relief formulations. Consumers should stop using the recalled eye drops and return them for a refund.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | NDC / UPC | Recall # |
|---|---|---|---|
| Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL)… | 3J1V, 2026 | UPC 310742010749, NDC 10742-8141-1 | D-0722-2026 |
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL) | 3H2V, 3H3V, 2026 | UPC 310742011012, NDC 10742-8158-1 | D-0716-2026 |
| Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL) | 4B1V, 4B1VA, 2027 | UPC 310742010602, NDC 10742-8175-1 | D-0719-2026 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL) | 4G1VA, 2027 | UPC 310742011135, NDC 10742-8162-1 | D-0720-2026 |
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL… | 3H1V, Date2026 | UPC 310742011210, NDC 10742-8158-2 | D-0717-2026 |
| Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile… | 3H1V, 3H1VA, 2025 | UPC 310742010916, NDC 10742-8160-1 | D-0718-2026 |
| Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL… | 3H1V, 2026, 6C1V, 2029 | UPC 310742010862, NDC 10742-8146-1 | D-0715-2026 |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each | 4G1V, 2027 | UPC 310742011159, NDC 10742-8162-2 | D-0721-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification