Español
TemporaryFDAOngoing

Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.

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

Check the label for

Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Why
Lack of Assurance of Sterility
Distributed
Nationwide within the United States
Company
Rohto-Mentholatum (Vietnam) Co., Ltd.
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222

Source: FDA record D-0719-2026 · retrieved 23 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.

Local Recall