Recall Weekly
Moderate riskFDA DrugClass II

Rohto Cooling Eye Drops Max Strength recalled for lack of sterility assurance

Rohto Cooling Eye Drops Max Strength in certain lots may not be sterile. The manufacturer cannot assure that these drops meet sterility standards required for safe eye use. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the lot number and expiration date on your bottle against the recalled lots listed in the recall notice.
  2. Stop using the product if your lot number matches one of the recalled lots.
  3. Discard the recalled product or return it to where you purchased it.
  4. Contact your eye care provider if you have used this product and experience eye irritation or infection.
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 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
UPC code
  • 310742011012
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 8 products — see all of them.

Details

Units affected
6076306 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-0716-2026

In the FDA's words

Description
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1 Lack of Assurance of Sterility Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08. Distribution: Nationwide within the United States Affected quantity: 6076306 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.

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