Recall Weekly
Moderate riskFDA DrugClass II

Rohto Cooling Eye Drops recalled for lack of assurance of sterility

Rohto Cooling Eye Drops ALL-IN-ONE in specific lots does not meet sterility standards required for eye products. The issue was identified during manufacturing quality checks. Affected lots are distributed nationwide and are sold in pharmacies and retailers.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the lot number and expiration date on your bottle against the FDA list
  2. Stop using the product if it matches an affected lot
  3. Dispose of the bottle safely or return it to the retailer
  4. Contact your eye care provider if you have experienced any eye irritation or discomfort
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
UPC code
  • 310742010862
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 8 products — see all of them.

Details

Units affected
1.033,266 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-0715-2026

In the FDA's words

Description
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 Lack of Assurance of Sterility 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. Distribution: Nationwide within the United States Affected quantity: 1.033,266 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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