Drug FDA Class III Terminated Sub/super-potent

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

Island Kinetics, Inc. d.b.a. CoValence Laboratories Published Apr 22, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Island Kinetics, Inc. d.b.a. CoValence Laboratories or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Subpotent Drug

Hazards

Subpotency · primary

Affected products (1)

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

299 bottles

Lot codes: 4212D4

Code info: Lot 4212D4; Exp. 07/31/2026

Affected areas

Nationwide

Timeline

Initiated

Mar 18, 2026
Published

Apr 22, 2026
Terminated

Jun 17, 2026

Recall number: D-0482-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.