ROYALAB Germ Away Antibacterial Hand Soap recall
FDA recall D-0090-2025 · initiated Nov 6, 2024
Midlab Incorporated recalled ROYALAB Germ Away Antibacterial Hand Soap in Nov 2024 — an FDA Class II recall (D-0090-2025) because cGMP Deviations: Out of specification results for micro in hand soap products.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Out of specification results for micro in hand soap products.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Midlab Incorporated
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 6, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was ROYALAB Germ Away Antibacterial Hand Soap recalled?
- Midlab Incorporated recalled ROYALAB Germ Away Antibacterial Hand Soap in Nov 2024 — an FDA Class II recall (D-0090-2025) because cGMP Deviations: Out of specification results for micro in hand soap products. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was ROYALAB Germ Away Antibacterial Hand Soap recalled?
- Per the FDA enforcement record, the reason for recall D-0090-2025 was: cGMP Deviations: Out of specification results for micro in hand soap products.
- Is a recalled ROYALAB Germ Away Antibacterial Hand Soap dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of ROYALAB Germ Away Antibacterial Hand Soap are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 0711241. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0090-2025.