Hydrocortisone Balm Recall by Island Kinetics

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Island Kinetics, Inc. is recalling 2895 bottles of Skin Rehab Calming Skin Gel Hydrocortisone Balm due to subpotency, affecting products distributed nationwide in the U.S.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Island Kinetics, Inc., doing business as CoValence Laboratories, has initiated a voluntary recall of certain batches of their hydrocortisone product because it is subpotent, meaning it does not contain the full intended strength of the active ingredient.

Which Products Are Affected

The affected product is Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, with NDC 66915-531-04. It was distributed by A.C.E. Inc., DFW Intl. Airport, Texas 75261. The recall involves 2895 bottles with Lot 4212D2 and expiration date 07/03/2026. The distribution was U.S. nationwide.

What You Should Do

Consumers who have the affected product should follow the initial firm notification, which was communicated via letter, and contact the recalling firm at Island Kinetics, Inc., 460 S Benson Ln Ste 1-3, Chandler, AZ 85224-5663 for instructions on returns or refunds. The official recall number is D-0481-2026.

Why This Matters

This recall addresses a subpotent drug that may not deliver the expected therapeutic benefits, potentially impacting users who rely on the product for skin care needs. It highlights the importance of ensuring pharmaceutical potency to maintain consumer safety and efficacy.

Source

This recall information is attributed to the FDA, based on their records. For more details, visit the FDA website at the recall page for event ID 98624.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Island Kinetics, Inc. is recalling 2895 bottles of Skin Rehab Calming Skin Gel Hydrocortisone Balm due to subpotency, affecting products distributed nationwide in the U.S.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.