FDA recall, , Moderate risk
Rohto Cooling Eye Drops
Rohto Cooling Eye Drops lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Rohto-Mentholatum (Vietnam) Co., Ltd., based in Ho Chi Minh, Vietnam, recalled several Rohto Cooling Eye Drops products distributed nationwide by The Mentholatum Company of Orchard Park, NY, because of a lack of assurance of sterility. The recall began on July 14, 2026, and was added to the FDA's Enforcement Report on July 23, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
8 products
Affected if its lot code and NDC or UPC are listed under that product.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 fl oz (13 mL) each
- NDC or UPC
- UPC 310742010749
- NDC 10742-8141-1
- Lot code
- 3J1V
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 fl oz (13 mL)
- NDC or UPC
- UPC 310742011012
- NDC 10742-8158-1
- Lot code
- 3H2V
- 3H3V
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 fl oz (13 mL)
- NDC or UPC
- UPC 310742010602
- NDC 10742-8175-1
- Lot code
- 4B1V
- 4B1VA
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 fl oz (10 mL)
- NDC or UPC
- UPC 310742011135
- NDC 10742-8162-1
- Lot code
- 4G1VA
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, Twin Pack, 0.4 fl oz (13 mL)
- NDC or UPC
- UPC 310742011210
- NDC 10742-8158-2
- Lot code
- 3H1V
- Date2026
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 fl oz (13 mL)
- NDC or UPC
- UPC 310742010916
- NDC 10742-8160-1
- Lot code
- 3H1V
- 3H1VA
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)
- NDC or UPC
- UPC 310742010862
- NDC 10742-8146-1
- Lot code
- 3H1V
- 6C1V
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, Twin Pack 0.34 fl oz (10 mL) each
- NDC or UPC
- UPC 310742011159
- NDC 10742-8162-2
- Lot code
- 4G1V
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Rohto-Mentholatum (Vietnam) Co., Ltd.Ho Chi Minh, Vietnam
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99440
- Recall numbers
- D-0715-2026 to D-0722-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
