Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0481-2026·Announced 2026-04-22

Skin Rehab calming hydrocortisone balm recalled as a subpotent drug

Skin Rehab Calming Skin Gel Hydrocortisone Balm, hydrocortisone 1%, is being recalled because the product is subpotent. The action covers 2,895 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

Skin Rehab Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, in 0.53 oz (15.3 g) bottles, NDC 66915-531-04, is being recalled. The product is distributed by A.C.E. Inc. of DFW International Airport, Texas. The action covers 2,895 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 4212D2, expiry 07/03/2026. 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: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Manufacturer: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Category: Drug — Topical corticosteroid
Hazard: subpotent
potency-failure
class-iii
otc-drug
Affected units: 2,895

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 4212D2
Exp. 07/03/2026

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 →

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

See all →

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Moderate
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Low
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Same hazard · subpotent