Hearth Record

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free

Medicine recall D-0656-2021. Published in FDA’s Enforcement Report on Jul 21, 2021.

  • FDA Class I
FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Jul 21, 2021. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class I, the most serious of FDA’s three classes.

“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”

openFDA, in plain words, its enforcement report fields.

“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.”

FDA’s rule, 21 CFR 7.3(m)(1), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Microbial Contamination of Non-Sterile Products: firm’s internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243

8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL, in FDA’s words.

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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,…

Every code shown here, 596 characters

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, DHS052020B1-S, DHS052020C1-S, Exp. 6/20/2022; DHS052220B1-S, Exp. 6/22/2022; DHS052620B1-S, Exp. 6/26/2022; DHS052720C1-S, DHS052720D1-S, Exp. 6/27/2022, DHS052820B1-S, DHS052820C1-S, DHS052820D1-S, Exp. 6/28/2022; DHS060120A1-S, Exp. 7/1/2022; DHS060220A1-S, DHS062220C-S, Exp. 7/22/2022

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Barcodes and drug codes

  • UPC 852379006141
  • UPC 852379006349
  • UPC 852379006127
  • UPC 852379006129
  • UPC 852379006356
  • UPC 852379006110
  • UPC 852379006974
  • UPC 852379006202
  • UPC 850008485077
  • UPC 852379006103
  • UPC 852379006219
Source:

As FDA’s description and codes give them; the UPCs written as digits only.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Nationwide in the USA and Bahamas

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Mar 10, 2021.
  • FDA classified it on Jul 13, 2021.
  • FDA’s Enforcement Report published it on Jul 21, 2021.
  • FDA terminated it on Jan 19, 2022.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Sanit Technologies, LLC dba Durisan, of Sarasota, FL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Drug recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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