PlainRecalls
FDA Drug Verify with FDA Drug → Moderate Class II Terminated

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.

Reported: August 5, 2020 Initiated: June 25, 2020 #D-1412-2020 18, 126 bottles units

POLARIZED LLC issued this FDA Drug recall on August 5, 2020. Classified as Moderate severity (Class II). Approximately 18, 126 bottles units are affected. The recall was issued because: CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared metha…. 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-1412-2020) was formally reported on August 5, 2020, with the manufacturer initiating the action on June 25, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. POLARIZED LLC is listed as the recalling firm, operating out of Lewes, DE. Federal records indicate 18, 126 bottles units are affected.

The documented reason for this recall is: CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol. Distribution data in the federal record shows the product reached: Distributed in VA with potential for Nationwide distribution in 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. 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

Moderate

Units Affected

18, 126 bottles

Related Recalls

6

0 from same agency

Product Description

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.

Reason for Recall

CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.

Details

Recalling Firm
POLARIZED LLC
Units Affected
18, 126 bottles
Distribution
Distributed in VA with potential for Nationwide distribution in USA
Location
Lewes, DE

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1412-2020
Date reported August 5, 2020
Date initiated June 25, 2020
Recalling firm POLARIZED LLC
Units affected 18, 126 bottles
Distribution Distributed in VA with potential for Nationwide distribution in USA

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

Scale of Impact

18, 126 bottles units affected — limited or regional distribution scale.

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

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?
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.. Recalled by POLARIZED LLC. Units affected: 18, 126 bottles.
Why was this product recalled?
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 5, 2020. Severity: Moderate. Recall number: D-1412-2020.
Where was the recalled product distributed?
Distribution: Distributed in VA with potential for Nationwide distribution in USA.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1412-2020) 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 moderate severity, indicating the product may cause temporary or medically reversible health consequences. 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.

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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.

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).