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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 6 recalled by Midlab Incorporated under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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