FDA Recall D-0090-2025
Midlab Incorporated · Athens, TN
Class II Ongoing 554 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall record
- Recall number
D-0090-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-11-06
- Classified by FDA Center
- 2024-12-02
- FDA published
- 2024-12-11
- Recalling firm
- Midlab Incorporated
- Firm location
- Athens, TN
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.