FDAFDA recall D-0719-2026 · Jul 29, 2026
Rohto-Mentholatum (Vietnam) Co., Ltd.: Rohto Cooling Eye Drops Digi Eye (hypromellose 0 recall
Recall found
Product
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
Reason for recall
Lack of Assurance of Sterility
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
- Quantity
- 65219 cartons
- Distribution
- Nationwide within the United States
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd., Ho Chi Minh, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-14
Source: openFDA enforcement record D-0719-2026 · search recall number D-0719-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.