FDA Recall of Essential Calming Skin Gel Due to Subpotency
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 299 bottles of Essential Calming Skin Gel because the product is subpotent, affecting its intended effectiveness.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
The recall was initiated due to the product being subpotent, meaning it does not contain the full amount of active ingredient as specified.
Which Products Are Affected
The affected product is Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, distributed by A.C.E. Inc., DFW Intl. Airport, Texas 75261, with NDC 66915-531-05. The recall involves 299 bottles from Lot 4212D4, with an expiration date of 07/31/2026. This recall is for products distributed nationwide in the United States.
What You Should Do
Consumers should contact the recalling firm, Island Kinetics, Inc. d.b.a. CoValence Laboratories, at their address: 460 S Benson Ln Ste 1-3, Chandler, AZ 85224-5663, as the initial notification was made via letter. Follow instructions for returns or refunds as provided by the firm.
Why This Matters
This recall highlights potential quality issues in pharmaceutical products, emphasizing the importance of verifying product potency for safe use, though it is classified as Class III with low risk of adverse health consequences.
Source
Attribution: FDA. For more information, visit the FDA website and search for recall number D-0482-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,203 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.