Essential Calming Skin Gel Recalled for Subpotent Drug

Key Takeaways

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. The affected batch has been identified as Lot 4212D4 (expiration date July 21, 2026), which contains 299 bottles.
• The recall was initiated by Island Kinetics, Inc dba CoValence Laboratories due to a subpotent drug, which makes the product less effective.
• Essential Calming Skin Gel is used to calm skin irritation and inflammation.

The FDA has issued a Class III recall for Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. This medication is distributed nationwide by A.C.E. Inc in Texas and manufactured by Island Kinetics, Inc in Chandler, Arizona. The recall was initiated on March 18, 2026, and was classified as a Class III recall on April 14, 2026. This recall affects 299 bottles.

The recall was initiated due to a subpotent drug, specifically for Lot 4212D4, which has an expiration date of July 31, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences. Island Kinetics sent out a public notice via letter; no public press release has been issued for this recall.

Essential Calming Skin Gel is a hydrocortisone cream used to calm skin irritation and inflammation resulting from rashes, burns, and insect bites. Pharmacists should identify and quarantine Lot 4212D4, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. April 22, 2026. Accessed April 22, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219258