The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0656-2021·Announced 2021-07-21

Durisan Antimicrobial Hand Sanitizer recalled for microbial contamination

Sanit Technologies is recalling Durisan Antimicrobial Solutions hand sanitizer due to internal testing that found contamination with Burkholderia contaminans and/or yeast and mold in certain lots.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, and the source text identifies microbial contamination (Burkholderia contaminans, yeast, and mold) in a non-sterile product intended for topical use. Class I recalls require a severity score of at least 4 per the rubric.

Plain-English summary

Sanit Technologies, LLC dba Durisan is recalling Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer in multiple sizes and package types nationwide in the USA and Bahamas. The recall affects 8,609,863 credit card size containers (0.61 fl oz, 18 mL), 665,395 bottles in various sizes ranging from 1.69 oz to 128 oz, and 70,462 kidney bottles. The product is labeled as 0.1% or 0.13% benzalkonium chloride and is alcohol-free.

The recall was initiated after the firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold. Affected lot codes include: DHS030920A1-A, DHS030920A2-S, DHS030920A3-S (Exp. 4/9/2022); DHS031020A4-S, DHS031020A5-S, DHS031020A6-S, DHS031020A7-S, DHS031020A8-S (Exp. 4/10/2022); DHS031120A1-S, DHS031120A2-S, DHS031120A3-S, DHS031120A4-S, DHS031120A5-S, DHS031120A6-S (Exp. 4/11/2022); and others with expiration dates through July 22, 2022.

Consumers who have purchased Durisan Antimicrobial Solutions hand sanitizer should stop using the product if they have one of the affected lots and contact the manufacturer for instructions. The FDA classifies this as a Class I recall.

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

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: DHS030920A1-A
  • DHS030920A2-S
  • DHS030920A3-S
  • Exp. 4/9/2022
  • DHS031020A4-S
  • DHS031020A5-S
  • DHS031020A6-S
  • DHS031020A7-S
  • DHS031020A8-S
  • Exp. 4/10/2022
  • DHS031120A1-S
  • DHS031120A2-S
  • DHS031120A3-S
  • DHS031120A4-S
  • DHS031120A5-S
  • DHS031120A6-S
  • Exp.4/11/2022
  • DHS051420A1-S
  • Exp. 6/14/2022
  • DHS052020A1-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 →

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