The Recall Desk
HighFDA (Drugs)·D-0090-2025·Announced 2024-12-11

ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing

Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with out-of-specification microbiological test results in a hand soap product intended to be antimicrobial. No illnesses or injuries have been reported. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap, 1-gallon size (Lot 0711241). The recall is due to Current Good Manufacturing Practice (cGMP) deviations. Microbiological testing revealed out-of-specification results in the product, indicating it fails to meet manufacturing quality standards for microbial contamination levels.

The affected product was distributed nationwide throughout the USA. Consumers who have purchased this product should discontinue use. For questions or concerns, contact Midlab Incorporated or consult a healthcare provider.

The recalled product

Product
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Manufacturer
Midlab Incorporated
Category
Drug — Antibacterial Hand Soap
Hazard
  • microbial-contamination
  • manufacturing-defect

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 0711241

Distribution

Distributed nationwide across the United States.

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