Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl.
Summary
The FDA issued a Class III for Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, by Island Kinetics, Inc. d.b.a. CoValence Laboratories. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0482-2026
Action Date
2026-04-22
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot 4212D4; Exp. 07/31/2026
Quantity Affected: 299 bottles
Reason for Recall
Subpotent Drug
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-18
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 94 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Island Kinetics, Inc. d.b.a. CoValence Laboratories has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Island Kinetics, Inc. d.b.a. CoValence Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Island Kinetics, Inc. d.b.a. CoValence Laboratories have FDA actions?
Island Kinetics, Inc. d.b.a. CoValence Laboratories has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0482-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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