CLASS II Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
Rohto Redness Relief, ice, Redness Reliever, Lubricant recalled
The Mentholatum is recalling Rohto Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net, distributed nationwide in the US. The recall was initiated on 16 Jan 2014 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-1038-2014
- FDA event ID
- 67314
- Recalling firm
- The Mentholatum, Orchard Park, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2014
- FDA classified
- 28 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 16 Jan 2014 | Recall initiated by company | |
| 28 Jan 2014 | Classified by FDA | +12 days |
| 5 Feb 2014 | Published in enforcement report | +8 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: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
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 Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Which lots are affected?
Stock No: 1086; Case UPC: 3 10742 91086 (5); Item UPC 3 10742 01086 2
Where was it sold?
Nationwide and Puerto Rico
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 67314This product is part of a recall event; the main page for the event is Rohto Cooling Eye Drops, Itch Relief, Soothes Itch & Burn recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rohto Cooling Eye Drops, Itch Relief, Soothes Itch & Burn recalled | The Mentholatum | Sterility | Nationwide | |
| CLASS II | Rohto Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net recalled | The Mentholatum | Sterility | Nationwide | |
| CLASS II | Rohto Redness Relief, arctic, Redness Reliever recalled | The Mentholatum | Sterility | Nationwide | |
| CLASS II | Rohto Redness Relief, Cool, Redness Reliever recalled by The Mentholatum | The Mentholatum | Sterility | Nationwide |
More recalls from The Mentholatum
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%) recalledRed Cross Oral Pain Relief | The Mentholatum | Packaging Defects | Nationwide |
| Drug | CLASS II | WellPatch¿ Capsaicin Pain Relief Patch recalled by The Mentholatum | The Mentholatum | Other | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, Cool, Redness Reliever recalled by The Mentholatum | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, arctic, Redness Reliever recalled | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net recalled | The Mentholatum | Sterility | Nationwide |
Other Rohto Redness Relief recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rohto Redness Relief, Cool, Redness Reliever recalled by The Mentholatum | The Mentholatum | Sterility | Nationwide |
| Drug | CLASS II | Rohto Redness Relief, arctic, Redness Reliever recalled | The Mentholatum | Sterility | Nationwide |