The Recall Desk
ModerateFDA (Drugs)·D-0167-2026·Announced 2025-11-26

Hand-E-Foam Hand Sanitizer Recalled Due to Facility Manufacturing Defect

DermaRite Industries is recalling Hand-E-Foam hand sanitizer due to manufacturing quality violations and facility contamination concerns. The FDA classified this as a Class II recall.

What this means for you

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 recall is classified as Moderate because it is a precautionary FDA Class II recall with no reported illnesses or injuries and a theoretical hazard based on manufacturing conditions. The rubric specifies that voluntary precautionary recalls without reported harm are scored as Moderate.

Plain-English summary

Hand-E-Foam Benzethonium Chloride 0.20% hand sanitizer is being recalled by DermaRite Industries, LLC. The affected products are available in two sizes: 236mL containers (NDC 61924-102-08) and 1000mL containers (NDC 61924-102-34). All lots with expiration dates on or before August 2027 are included in this recall.

The recall was initiated due to a Current Good Manufacturing Practices (CGMP) deviation identified at the facility where Hand-E-Foam is produced. The manufacturing facility was found to have contamination issues affecting other products and lots. The FDA classified this as a Class II recall, indicating a potential health hazard.

The affected products were distributed nationwide throughout the United States. No illnesses or injuries have been reported at this time.

Consumers who have purchased Hand-E-Foam should stop using the product and contact DermaRite Industries for further instructions. Healthcare providers and the FDA are available to answer questions or concerns regarding this product.

The recalled product

Product
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Manufacturer
DermaRite Industries, LLC
Category
Drug — Over-the-Counter Antimicrobial Hand Sanitizer
Hazard
  • cgmp-deviation
  • facility-contamination

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)

  • All lots on or before expiry date 08/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category