Reported Jul 29, 2026 · Ongoing

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL…

Rohto-Mentholatum (Vietnam) Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rohto-Mentholatum (Vietnam) Co., Ltd. · No. 16 Vsip, Street No. 5 · Ho Chi Minh, N/A · N/A

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

Lot codes and dates: Lot #: 3H1V
Exp. Date 2026/07
3J1V
3J2V
Exp. Date 2026/09
3K1V
Exp. Date 2026/10
4A1V
4A2V
Exp. Date 2026/12
4B1V
4B2V
Exp. Date 2027/01
4G1V
4G2V
4G3V
Exp. Date 2027/06
4I1V
4I2V
4I2VA Exp. Date 2027/08
4J1V
4J2V
Exp. Date 2027/09
4K2V
4K3V
4K4V Exp. Date2027/10
5B1V
5B2V
5B3V
Exp. Date 2028/01
5D1V
Exp. Date 2028/03
5E1V
5E2V
5E3V
Exp. Date 2028/04
5H1V
Exp. Date 2028/07
5I1V
Exp. Date 2028/08
5J1V
5J2V
Exp. Date 2028/09
5L1V
5L1VA
5L1VB
5L1VC
5L1VD
5L2V
Exp. Date 2028/11
6A1V
6A2V
Exp. Date 2028/12
6B1V
Exp. Date 2029/01 & Lot 6C1V
Exp. Date 2029/02
Amount recalled: 1.033,266 cartons

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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