The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0659-2021·Announced 2021-07-21

Durisan Hand Sanitizing Wipes Recalled for CGMP Deviations

Sanit Technologies, LLC is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes (benzalkonium chloride, 0.13%) due to manufacturing deviations that could result in contaminated product.

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 issued due to CGMP deviations and manufacturing defects. The source text does not report any illnesses, injuries, or confirmed contamination in the recalled lots themselves—only that they were made under the same conditions as contaminated lots. Under the rubric, Class II recalls without reported illness or injury evidence are typically scored as Moderate (2).

Plain-English summary

Sanit Technologies, LLC dba Durisan is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes in three package sizes: 80-count canisters (UPC 852379006325), 160-count canisters (UPC 852379006318), and 240-count canisters (UPC 852379006332). The product contains 0.13% benzalkonium chloride. A total of 43,164 canisters have been recalled.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. According to the FDA, the recalled lots were manufactured under the same conditions as product lots that were found to be contaminated. The affected product was distributed nationwide in the USA and the Bahamas.

Consumers who have purchased this product should stop using it. For additional information about affected lot codes and expiration dates, consumers should contact the manufacturer or the FDA.

The recalled product

Product
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East…
Manufacturer
Sanit Technologies, LLC dba Durisan
Category
Drug — Hand Sanitizer
Hazard
Affected units
43,164

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)

  • 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 →

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