CoValence Laboratories recalls hydrocortisone 1% skin gel due to subpotent drug levels. This may not provide intended therapeutic effect. Check NDC 66915-531-05 and lot 4212D4 for affected products.
Subpotent Drug
CoValence Laboratories is recalling hydrocortisone 1% skin gel because it may not contain enough active ingredient to be effective. This could lead to inadequate treatment for skin conditions.
The product contains subpotent hydrocortisone, meaning it has less active ingredient than intended. This could result in the gel not working properly for skin inflammation or irritation. However, it does not cause immediate harm or injury.
People who own or use the recalled hydrocortisone 1% skin gel for skin conditions. Those with sensitive skin or chronic conditions may be most affected.
Check for the product name 'Essential Calming Skin Gel', hydrocortisone 1%, 120mL/4oz per jar. Look for NDC 66915-531-05 and lot number 4212D4 on the label.
Look for NDC 66915-531-05 and lot number 4212D4 on the product label.
The product may not be effective due to subpotent hydrocortisone levels, but it does not cause immediate harm or injury.
The recall does not specify a remedy, so check with your healthcare provider for advice on whether to continue using the product.
The product was distributed by A.C.E. Inc. at DFW International Airport, Texas.
We’ve drafted a message you can send CoValence Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0482-2026 — CoValence Laboratories CoValence Laboratories Hello, I own a CoValence Laboratories that is covered by recall D-0482-2026 from CoValence Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
