The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1357-2022·Announced 2022-08-24

Stage 2-Ophardt Foaming Hand Sanitizer Recalled Due to Microbial Control Deviation

Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential microbial contamination resulting from a manufacturing process deviation—not confirmed contamination. This qualifies as a precautionary recall.

Plain-English summary

Aire-Master of America Inc is recalling approximately 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL bottles, manufactured for 2XL Corporation.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured using deionized water from a system that lacked appropriate microbial control measures following the deionization process. This creates a potential for microbial contamination in the hand sanitizer.

The recalled product was distributed in Florida, Illinois, Iowa, and New Jersey. Affected product includes Lot 722712 (expiration 07/22), Lot 724755 (expiration 11/22), and Lot 725054 (expiration 12/22), with Product Number 46101.

The recalled product

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
Manufacturer
Aire-Master of America Inc
Category
Drug — Hand Sanitizer
Hazard
Affected units
4,632

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product Number 46101
  • Lots 722712-exp 07/22
  • 724755-exp 11/22
  • 725054-exp 12/22

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 6 recalled by Aire-Master of America Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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