Recall Weekly
Moderate riskFDA DrugClass II

Rohto Optic Glow eye drops recalled for lack of sterility assurance

Rohto Cooling Eye Drops Optic Glow may not meet sterility standards required for eye products. The manufacturer cannot confirm that certain batches were manufactured under proper sterile conditions. 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 FDA recall list.
  2. Stop using the product if it matches a recalled lot number.
  3. Consult your eye care provider if you have used this product and experience eye irritation or discomfort.
  4. Contact Mentholatum at the number on the package for disposal instructions or a refund.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
UPC code
  • 310742010916
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 8 products — see all of them.

Details

Units affected
1,278,457 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-0718-2026

In the FDA's words

Description
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1 Lack of Assurance of Sterility Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02. Distribution: Nationwide within the United States Affected quantity: 1,278,457 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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