Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0719-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 14, 2026
- FDA report date
- Jul 29, 2026
- Quantity
- 65219 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0719-2026, exactly as published.
Show all FDA fields
- City
- Ho Chi Minh
- Status
- Ongoing
- Country
- Vietnam
- Event ID
- 99440
- Address
- No. 16 Vsip, Street No. 5
- Address (line 2)
- Vietnam Singapore Industrial Park
- Code information
- Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
- Report date
- Jul 29, 2026
- Product type
- Drugs
- Recall number
- D-0719-2026
- Classification
- Class II
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co., Ltd.
- Product quantity
- 65219 cartons
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 14, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2026