CLASS II ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Rohto Cooling Eye Drops Dry Aid (povidone recalled
Rohto-Mentholatum (Vietnam) Co is recalling Rohto Cooling Eye Drops Dry Aid (povidone 68%, propylene glycol 3%), Sterile, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0720-2026
- FDA event ID
- 99440
- Recalling firm
- Rohto-Mentholatum (Vietnam) Co, Ho Chi Minh, N/A
- Brand
- Rohto Dry-aid
- Manufacturer
- The Mentholatum Company
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2026
- FDA classified
- 23 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 14 Jul 2026 | Recall initiated by company | |
| 23 Jul 2026 | Classified by FDA | +9 days |
| 29 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Rohto Cooling Eye Drops Dry Aid (povidone 68%, propylene glycol 3%), Sterile recalled?
Yes. Rohto-Mentholatum (Vietnam) Co recalled Rohto Cooling Eye Drops Dry Aid (povidone 68%, propylene glycol 3%), Sterile on 14 Jul 2026. The recall is Class II and its status is Ongoing. Recall number D-0720-2026.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Rohto-Mentholatum (Vietnam) Co
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |
| Drug | CLASS II | Rohto Cooling Eye Drops All-in-one (hypromellose recalledRohto | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |
| Drug | CLASS II | Rohto Cooling Eye Drops Optic Glow recalledRohto Optic Glow | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |
| Drug | CLASS II | Rohto Cooling Eye Drops Max Strength recalledRohto | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |
| Drug | CLASS II | Rohto Cooling Eye Drops Digi Eye (hypromellose recalledRohto Digi-eye | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |
Other Povidone, Propylene Glycol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rohto Cooling Eye Drops Dry Aid (povidone recalledRohto Dry-aid | Rohto-Mentholatum (Vietnam) Co | Sterility | Nationwide |