Severity
Moderate
FDA Drug recall · Reported December 11, 2024
cGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated recalled ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GAL… - a moderate-severity action.
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GAL… was recalled by Midlab Incorporated in December 11, 2024. Reason: cGMP Deviations: Out of specification results for micro in hand soap products.. Check the official notice for the remedy. Verify recall #D-0090-2025 with the FDA Drug before acting.
The recall
Midlab Incorporated issued this moderate-severity FDA Drug recall-cGMP Deviations: Out of specification results for micro in hand soap products..
Sourced from official FDA Drug enforcement records. Verify recall #D-0090-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0090-2025) was formally reported on December 11, 2024, with the manufacturer initiating the action on November 6, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Midlab Incorporated is listed as the recalling firm, operating out of Athens, TN. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: cGMP Deviations: Out of specification results for micro in hand soap products. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
Unknown
Related Recalls
6
3 from same agency
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
cGMP Deviations: Out of specification results for micro in hand soap products.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0090-2025 |
| Date reported | December 11, 2024 |
| Date initiated | November 6, 2024 |
| Recalling firm | Midlab Incorporated |
| Firm location | Athens, TN |
| Affected scope | Not disclosed |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 11, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.