Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0658-2021·Announced 2021-07-21

Durisan Antimicrobial Hand Sanitizer Recalled for Manufacturing Deviations

Sanit Technologies, LLC is recalling multiple lots of Durisan Antimicrobial Solutions hand sanitizer due to manufacturing deviations. The affected products were manufactured under the same conditions as contaminated lots.

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: This is an FDA Class II recall involving manufacturing deviations. The source text does not report any illnesses, injuries, or confirmed contamination in the recalled lots themselves—only that they were manufactured under the same conditions as contaminated lots. No adverse health events are documented, making this a precautionary recall that falls under the Moderate category.

Plain-English summary

Sanit Technologies, LLC dba Durisan is recalling multiple lots of Durisan Antimicrobial Solutions (benzalkonium chloride) hand sanitizer, listed as 0.1% or 0.13%, Alcohol-Free. The recalled product is available in multiple package sizes ranging from 18 mL credit card containers to 1-gallon bottles with various UPCs.

The recall is due to manufacturing deviations. Specifically, the lots being recalled were manufactured under the same conditions as product lots that were found to be contaminated.

The affected lots are distributed nationwide in the USA and the Bahamas. Specific lot numbers and expiration dates are available from the FDA. Consumers who have purchased affected products should stop use and contact the manufacturer or consult with their healthcare provider if they have any concerns about product safety.

The recalled product

Product: Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379…
Manufacturer: Sanit Technologies, LLC dba Durisan
Category: Drug — Hand Sanitizer
Hazard: manufacturing-deviation
potential-contamination

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 (20)

Lots: DHS041519A1-S
DHS041519A2-S
DHS041519A3-S
DHS041519A4-S
DHS041519A5-S
DHS041519A6-S
Exp. 5/15/2021
DHS042919AR1-S
Exp. 5/29/2021
DHS043019AR1-S
Exp. 5/30/2021
DHS050319A4-S
Exp. 6/03/2021
DHS053019A1-S
DHS053019A2-S
DHS053019A4-S
DHS053019A5-S
DHS053019A6-S
Exp. 6/30/2021
DHS070219A1-S

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Sanit Technologies, LLC dba Durisan 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 4 products in this recall →

Same manufacturer · Sanit Technologies, LLC dba Durisan

See all →

Moderate
Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations
FDA (Drugs) · 2021-07-21
Severe
Durisan Hand Sanitizing Wipes Recalled for Microbial Contamination
FDA (Drugs) · 2021-07-21
Severe
Durisan Antimicrobial Hand Sanitizer recalled for microbial contamination
FDA (Drugs) · 2021-07-21

Same hazard · manufacturing deviation