The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0482-2026·Announced 2026-04-22

Rhonda Allison calming skin gel recalled as a subpotent hydrocortisone product

Essential Calming Skin Gel containing 1% hydrocortisone is being recalled because the product is subpotent. The action covers 299 bottles.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall for subpotency, which the rubric places in the 1-2 band; a potency shortfall rather than a purely cosmetic issue puts it at Moderate.

Plain-English summary

Essential Calming Skin Gel, hydrocortisone 1%, in 120 mL / 4 oz jars, NDC 66915-531-05, is being recalled. The product is distributed by A.C.E. Inc. of DFW International Airport, Texas. The action covers 299 bottles.

The stated reason is that the drug is subpotent, meaning it contains less active ingredient than the label declares. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.

The affected lot is 4212D4, expiry 07/31/2026. Distribution was US nationwide.

Consumers who have the affected lot should stop using it and contact the retailer or the firm about a refund or replacement.

The recalled product

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
Manufacturer
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Category
Drug — Topical corticosteroid
Hazard
Affected units
299

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 4212D4
  • Exp. 07/31/2026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Island Kinetics, Inc. d.b.a. CoValence Laboratories under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Island Kinetics, Inc. d.b.a. CoValence Laboratories

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Same hazard · subpotent

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