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Serious recall: Injury is possible or has been reported. Take action promptly.

Rohto-Mentholatum (Vietnam) Co., Ltd. 2026-07-29 Health serious FDA
Health · FDA · Recall #FDA-D-0716-2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90,… Recall

Issued July 29, 2026 · Rohto-Mentholatum (Vietnam) Co., Ltd.

In July 2026, Rohto-Mentholatum (Vietnam) Co., Ltd. recalled the Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90,…, a serious health recall reported by the FDA.

Compiled by Dana Whitfield, RecallCheckr

What this means for you

Lack of Assurance of Sterility

What you should do

  1. 1 Stop using Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Rohto-Mentholatum (Vietnam) Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Health
Recall date
July 29, 2026
Units affected
Not reported
Sold at
Nationwide within the United States
Recall number
FDA-D-0716-2026
Made in
Vietnam
Issuing agency
FDA

In context

Read the official FDA notice

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