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Food & drug recall · FDAJuly 14, 2026Serious

Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL)

Check whether yours is affected, then follow the instructions below.

What’s wrong

Lack of Assurance of Sterility

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have, and follow the FDA recall notice for what to do with the affected product. If you use it daily, or it is for a child, your pharmacist can tell you whether it matters and what to use instead.

Who to contact: Recalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.

The 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

Details

Units affected
65219 cartons
Recall date
July 14, 2026
Brand
Rohto-Mentholatum (Vietnam) Co., Ltd.
Model, lot or SKU numbers
Lot #: 4B1V, 4B1VA, Exp. Date 2027/014J1V, Exp. Date 2027/09
Barcodes (UPC)
310742010602
Where it was distributed

Nationwide within the United States

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Rohto-Mentholatum (Vietnam) Co., Ltd. — 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 310”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Over-the-counter & supplements

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