CLASS I Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
kleantouch Hand Sanitizer (ethyl alcohol 70%), pump recalled
Valisa MFG is recalling kleantouch Hand Sanitizer (ethyl alcohol 70%), pump, distributed nationwide in the US. The recall was initiated on 6 Dec 2021 and the FDA has classified it as Class I.
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-0363-2022
- FDA event ID
- 89186
- Recalling firm
- Valisa MFG, Farmingdale, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Dec 2021
- FDA classified
- 10 Jan 2022
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Drug class
- Hand Sanitizer
Timeline
| 6 Dec 2021 | Recall initiated by company | |
| 5 Jan 2022 | Published in enforcement report | +30 days |
| 10 Jan 2022 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Which lots are affected?
Lot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022
Where was it sold?
Nationwide in the USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.