The Recall Desk
SevereFDA (Drugs)·D-1412-2020·Announced 2020-08-05

Saniderm Hand Sanitizer Recalled for Undeclared Methanol and Low Ethanol

Polarized LLC is recalling Saniderm Advanced Hand Sanitizer because it contains undeclared methanol and less ethanol than labeled.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of undeclared methanol in a topical product poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Polarized LLC is recalling Saniderm Advanced Hand Sanitizer, 70% Alcohol Content, 1 Liter bottles. The recall involves 18, 126 bottles distributed in Virginia, with potential for nationwide distribution in the United States. The product is produced by Eskbiochem SA de CV in Mexico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing revealed that the product contained less ethanol than the label claim and included undeclared methanol. Methanol is a toxic substance that can cause serious health effects if absorbed through the skin or ingested.

Consumers who have purchased this product should stop using it immediately. The specific lot number is not limited to a single batch; the recall includes all lots, including lot number 53131626. The product can be identified by the UPC 8 60003 63391 5.

The recalled product

Product
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.
Manufacturer
POLARIZED LLC

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 (1)

  • Lot # all lots to include 53131626

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: