Essential Calming Skin Gel recall
FDA recall D-0482-2026 · initiated Mar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories recalled Essential Calming Skin Gel in Mar 2026 — an FDA Class III recall (D-0482-2026) because Subpotent Drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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.
Quantity recalled: 299 bottles
Details
- Product
- 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 company
- Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Mar 18, 2026
- FDA report date
- Apr 22, 2026
Frequently asked
- Was Essential Calming Skin Gel recalled?
- Island Kinetics, Inc. d.b.a. CoValence Laboratories recalled Essential Calming Skin Gel in Mar 2026 — an FDA Class III recall (D-0482-2026) because Subpotent Drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Essential Calming Skin Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0482-2026 was: Subpotent Drug
- Is a recalled Essential Calming Skin Gel 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 Essential Calming Skin Gel are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot 4212D4; Exp. 07/31/2026. 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-0482-2026.