Recall Weekly
Moderate riskFDA DrugClass II

Rohto Cooling Eye Drops recalled for lack of assurance of sterility

Rohto Cooling Eye Drops Max Strength (a nasal decongestant eye drop product) was distributed without assurance that all units met sterility standards. The product is used directly in the eye, where any contamination could pose a risk of infection. This recall affects specific lot numbers distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the lot number on your Rohto Cooling Eye Drops Max Strength twin pack against the list provided (3H1V through 6C2V with various expiration dates through 2029).
  2. Do not use the product if your lot number matches any on the recall list.
  3. Contact Mentholatum Company or your retailer for instructions on disposal or replacement.
  4. If you have used this product and experience eye redness, irritation, or discharge, contact your eye care provider.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
UPC code
  • 310742011210
Sold in
Nationwide
Made for
All ages

This recall covers 8 products — see all of them.

Details

Units affected
499,673 cartons
Illnesses reported
None reported
Manufactured in
No. 16 Vsip, Street No. 5, Vietnam Singapore Industrial Park, Ho Chi Minh, N/A, Vietnam
Classification
Class II
Recall number
D-0717-2026

In the FDA's words

Description
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 Lack of Assurance of Sterility 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 Affected quantity: 499,673 cartons
Hazard
Lack of Assurance of Sterility

8 products in this recall

Rohto Cooling Eye Drops recalled for sterility concerns

Rohto-Mentholatum is recalling eight Rohto Cooling Eye Drops products because they lack assurance of sterility, meaning the drops may not be guaranteed free of microbial contamination. All eight are sold under the Rohto Cooling Eye Drops name: ALL-IN-ONE, Max Strength (three versions), Optic Glow, Digi Eye, Dry Aid (single and twin pack), and Cool Relief. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

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