Rohto-Mentholatum (Vietnam) Co., Ltd. recalls

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0716-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0722-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0719-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0720-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0717-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0718-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
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

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0715-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1

Recall status
Ongoing

Hazard
Lack of Assurance of Sterility

Details
Distribution: Nationwide within the United States. Recall #D-0721-2026, initiated 20260714. Voluntary: Firm initiated.

Products affected
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

Recall status
Ongoing