RecallRadar

FDA Drug recall D-0363-2022

kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, M…

On 2022-01-05 the FDA classified a Class I recall of kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, M… by Valisa Mfg, citing marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0363-2022
ClassificationClass I
Statusterminated
Initiated2021-12-06
Published2022-01-05
Last updated2026-09-13 11:52 UTC
CompanyValisa Mfg
DistributionUS

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

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Identifiers

upc686162992461
code_infoLot #: 1260-1, 1260-2, 1260-3, 1260-4. Exp. 04/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0363-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.