Severity
Moderate
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
Reported: July 21, 2021 Initiated: March 10, 2021 #D-0658-2021 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL units
Sanit Technologies, LLC dba Durisan issued this FDA Drug recall on July 21, 2021. Classified as Moderate severity (Class II). Approximately 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL units are affected. The recall was issued because: CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as produ…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-0658-2021) was formally reported on July 21, 2021, with the manufacturer initiating the action on March 10, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Sanit Technologies, LLC dba Durisan is listed as the recalling firm, operating out of Sarasota, FL. Federal records indicate 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. Distribution data in the federal record shows the product reached: Nationwide in the USA and Bahamas. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL
Related Recalls
6
0 from same agency
Product Description
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
Reason for Recall
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Details
- Recalling Firm
- Sanit Technologies, LLC dba Durisan
- Units Affected
- 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL
- Distribution
- Nationwide in the USA and Bahamas
- Location
- Sarasota, FL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0658-2021 |
| Date reported | July 21, 2021 |
| Date initiated | March 10, 2021 |
| Recalling firm | Sanit Technologies, LLC dba Durisan |
| Units affected | 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL |
| Distribution | Nationwide in the USA and Bahamas |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was 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. Recalled by Sanit Technologies, LLC dba Durisan. Units affected: 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL.
Why was this product recalled? ▼
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 21, 2021. Severity: Moderate. Recall number: D-0658-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Bahamas.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0658-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).