Rohto-Mentholatum (Vietnam) Co., Ltd.
Rohto-Mentholatum (Vietnam) Co., Ltd. appears in FDA public data with 8 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0722-2026, Class II) was initiated on July 14, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0722-2026 | Class II | Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile | July 14, 2026 |
| D-0719-2026 | Class II | Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL O | July 14, 2026 |
| D-0717-2026 | Class II | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile | July 14, 2026 |
| D-0718-2026 | Class II | Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol | July 14, 2026 |
| D-0715-2026 | Class II | Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25 | July 14, 2026 |
| D-0721-2026 | Class II | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL | July 14, 2026 |
| D-0720-2026 | Class II | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL) | July 14, 2026 |
| D-0716-2026 | Class II | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Steril | July 14, 2026 |