CLASS II ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report

Rohto Cooling Eye Drops All-in-one (hypromellose recalled

Rohto-Mentholatum (Vietnam) is recalling Rohto Cooling Eye Drops All-in-one (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

NDC10742-8146

UPC0310742010862, 310742010862

Quantity recalled1.033,266 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0715-2026
FDA event ID: 99440
Recalling firm: Rohto-Mentholatum (Vietnam), Ho Chi Minh, N/A
Brand: Rohto
Manufacturer: The Mentholatum Company
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jul 2026
FDA classified: 23 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

14 Jul 2026	Recall initiated by company
23 Jul 2026	Classified by FDA	+9 days
29 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

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.

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 99440

This product is part of a recall event; the main page for the event is Rohto Cooling Eye Drops Max Strength recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Cool Relief recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide

More recalls from Rohto-Mentholatum (Vietnam)

All 8

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Max Strength recalledRohto	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide

Other Hypromellose recalls

All 6

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye	Rohto-Mentholatum (Vietnam)	Sterility	Nationwide
6 May 2026Drug	CLASS II	Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane	Alcon Research	Sterility	Nationwide
6 May 2026Drug	CLASS II	GenTeal Tears, Lubricant Eye Gel, Sterile recalled by Alcon ResearchGenteal Tears	Alcon Research	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution recalledVista Gonio Eye Lubricant	Wizcure Pharmaa Private	Sterility	Nationwide
4 Mar 2026Drug	CLASS II	Vista Gel Hypromellose USP 0.3% w/v recalled by Wizcure Pharmaa PrivateVista Hypromellose Dry Eye Relief	Wizcure Pharmaa Private	Sterility	Nationwide