CLASS I Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients recalled
Aroma Release Technologies is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in drums, distributed in New York, Texas. The recall was initiated on 30 Nov 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-0298-2022
- FDA event ID
- 89138
- Recalling firm
- Aroma Release Technologies, Chattanooga, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Nov 2021
- FDA classified
- 28 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Drug class
- Hand Sanitizer
Timeline
| 30 Nov 2021 | Recall initiated by company | |
| 28 Dec 2021 | Classified by FDA | +28 days |
| 5 Jan 2022 | 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
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
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
Where it was distributed
Distributed in the states of Texas and New York.
Questions about this recall
Is Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in drums recalled?
Yes. Aroma Release Technologies recalled Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in drums on 30 Nov 2021. The recall is Class I and its status is Terminated. Recall number D-0298-2022.
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?
Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
Where was it sold?
Distributed in the states of Texas and New York.
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 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.