Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Essential Calming Skin Gel
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
What was recalled
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
- Recalling firm
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
- NDC code
- 66915-531-05
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0482-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydrocortisone recalls
See all
Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk Terminated
Skin Rehab
Reason Subpotent Drug
Class III · Low risk Terminated
Remedy Gel
Reason Subpotent Drug
Class II · Moderate risk Terminated
Rapidol Maximum Strength
Reason CGMP Deviations
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