Remedy Gel Recall: FDA Issues Alert for Subpotent Drug

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.

The FDA has announced a voluntary recall of 1060 bottles of Remedy Gel, hydrocortisone 1%, due to subpotency, affecting products distributed nationwide in the United States.

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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Remedy Gel Recall

What Happened

Island Kinetics, Inc. d.b.a. CoValence Laboratories is recalling Remedy Gel, hydrocortisone 1%, because it is subpotent, meaning the drug may not contain the full intended potency.

Which Products Are Affected

The affected products are Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, distributed by glo Skin Beauty, Denver, CO 80216, with NDC codes 66915-531-12 and 66915-531-13. A total of 1060 bottles are involved, specifically lots 4155D2 and 4155D3, with an expiration date of 05/15/2026. The products were distributed nationwide in the United States.

What You Should Do

Consumers with the affected products should contact Island Kinetics, Inc. at their address: 460 S Benson Ln Ste 1-3, Chandler, AZ 85224-5663, as the recall was initiated via letter. For information on returns or refunds, reach out to the firm directly.

Why This Matters

This recall highlights potential issues with drug potency that could affect treatment effectiveness, but it is classified as Class III by the FDA, indicating a low risk of adverse health consequences.

Source

Attribution: FDA. For more information, refer to FDA Recall Number D-0480-2026 on the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has announced a voluntary recall of 1060 bottles of Remedy Gel, hydrocortisone 1%, due to subpotency, affecting products distributed nationwide in the United States.
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.