FDA Drugs recall ·
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%… recall
- Recall number
- D-0717-2026
- Date
- (initiated July 14, 2026)
- Company / brand
- Rohto-Mentholatum (Vietnam) Co., Ltd.
No. 16 Vsip, Street No. 5, Ho Chi Minh, N/A, Vietnam - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 499,673 cartons
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0717-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.