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Rohto-Mentholatum (Vietnam) Co., Ltd. FDA Recalls
8 recalls on file across drugs, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL),Class IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) Class IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, DisClass IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), DistributClass IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL Class IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4Class IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OClass IIJul 14, 2026Lack of Assurance of Sterility |
| Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: ThClass IIJul 14, 2026Lack of Assurance of Sterility |