kleantouch HAND SANITIZER — Class I drug recall D-0363-2022
Terminated recall by Valisa MFG LLC, reported 2022-01-05, distributed nationwide. Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug an
| Recall number | D-0363-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valisa MFG LLC, Farmingdale, NY, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2024-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 7,704 bottles |
| Reason classes | chemical contamination, labeling, unapproved product |
| UPC / GTIN / UDI-DI | 00686162992461 |
| Lot numbers | 1260-1, 1260-2, 1260-3, 1260-4 |
| Expiration dates | 2022-04 |
Product
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
Reason for recall
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0363-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.