PlainRecalls
FDA Drug Verify with FDA Drug → Critical Class I Terminated

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.

Reported: October 7, 2020 Initiated: July 11, 2020 #D-0029-2021 17,359,247 total bottles and pumps units

4e Brands North America, Llc issued this FDA Drug recall on October 7, 2020. Classified as Critical severity (Class I). Approximately 17,359,247 total bottles and pumps units are affected. The recall was issued because: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for et…. 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-0029-2021) was formally reported on October 7, 2020, with the manufacturer initiating the action on July 11, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. 4e Brands North America, Llc is listed as the recalling firm, operating out of San Antonio, TX. Federal records indicate 17,359,247 total bottles and pumps 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: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. 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, of which 5 were also issued by FDA Drug. 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 6 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

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Critical

Units Affected

17,359,247 total bottles and pumps

Related Recalls

6

5 from same agency

Product Description

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.

Reason for Recall

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

Details

Units Affected
17,359,247 total bottles and pumps
Distribution
Distributed Nationwide in the USA
Location
San Antonio, TX

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-0029-2021
Date reported October 7, 2020
Date initiated July 11, 2020
Recalling firm 4e Brands North America, Llc
Units affected 17,359,247 total bottles and pumps
Distribution Distributed Nationwide in the USA

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

17,359,247 total bottles and pumps units affected — million-unit bracket.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.. Recalled by 4e Brands North America, Llc. Units affected: 17,359,247 total bottles and pumps.
Why was this product recalled?
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2020. Severity: Critical. Recall number: D-0029-2021.
Where was the recalled product distributed?
Distribution: Distributed Nationwide in the USA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0029-2021) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

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.

All federal data sources used on this page

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).