Rohto Cooling Eye Drops recalled for lack of assurance of sterility
Rohto Cooling Eye Drops Digi Eye may not meet sterility standards required for eye products. The affected lots were distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have Rohto Cooling Eye Drops Digi Eye with lot numbers 4B1V, 4B1VA (expiration 2027/01), or 4J1V (expiration 2027/09).
- Stop using the product if you have an affected lot.
- Contact The Mentholatum Company or your pharmacist for instructions on safe disposal or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
- UPC code
- 310742010602
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 8 products — see all of them.
Details
- Units affected
- 65219 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-0719-2026
In the FDA's words
- Description
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1 Lack of Assurance of Sterility Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09 Distribution: Nationwide within the United States Affected quantity: 65219 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.
- 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 Mentho…D-0715-2026 · 1.033,266 cartons
- 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 Comp…D-0716-2026 · 6076306 cartons
- 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 Menth…D-0717-2026 · 499,673 cartons
- 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 M…D-0718-2026 · 1,278,457 cartons
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orcha… (this page)D-0719-2026 · 65219 cartons
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park,…D-0720-2026 · 97201 cartons
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company,…D-0721-2026 · 353 cartons
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum…D-0722-2026 · 2910148 cartons