Stage 2 Ophardt Hand Sanitizer (Aire-Master) – Production Flaw (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Brand
Aire-Master of America Inc
Lot Codes / Batch Numbers
Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Products Sold
Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Aire-Master of America Inc is recalling Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactu due to CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, IA, NJ
Page updated: Jan 7, 2026