CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall: Subpotent Drug Risk
CoValence Laboratories recalls hydrocortisone 1% Remedy Gel due to subpotent drug levels. Affected products have specific NDC and lot numbers. Consumers should contact the distributor for details.
Lower-risk recall
Subpotent Drug
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What happened, in plain English
CoValence Laboratories is recalling hydrocortisone 1% Remedy Gel because it may contain insufficient active ingredient. This could lead to ineffective treatment for skin conditions. The recall affects specific product batches with known NDC and lot numbers. Read more at govinfonow.com/recall/31419-covalence-laboratories-remedy-gel-hydrocortisone-1-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31419-covalence-laboratories-remedy-gel-hydrocortisone-1-recall-subpotent-drug-risk · Updated August 9, 2026 · FDA enforcement record: FDA #D-0480-2026
Cite this page
“CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall: Subpotent Drug Risk.” GovInfoNow, updated August 9, 2026. https://govinfonow.com/recall/31419-covalence-laboratories-remedy-gel-hydrocortisone-1-recall-subpotent-drug-risk. Based on FDA recall #D-0480-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0480-2026%22&limit=1).
Why it’s dangerous
The product may have subpotent hydrocortisone levels, meaning it contains less active ingredient than labeled. This could result in the gel not working properly for skin conditions. However, the risk is not severe enough to cause serious injury.
Who’s affected
People who purchased the Remedy Gel from glo Skin Beauty in Denver, CO, between the dates of distribution. Those with skin conditions requiring hydrocortisone treatment are most at risk.
How to tell if you have this one
Check for NDC numbers 66915-531-12 or 66915-531-13, and lot numbers 4155D2 or 4155D3. The product expires May 15, 2026, and was distributed by glo Skin Beauty in Denver, CO.
- Brand
CoValence Laboratories- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S. Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0480-2026 | Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13; Lot 4155D2, 4155D3; Exp. 05/15/2026 | 1060 bottles |
| D-0481-2026 | Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04; Lot 4212D2; Exp. 07/03/2026 | 2895 bottles |
| D-0482-2026 | Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05; Lot 4212D4; Exp. 07/31/2026 | 299 bottles |
What to do — step by step
Check Product Details
Look for NDC numbers 66915-531-12 or 66915-531-13 and lot numbers 4155D2 or 4155D3 on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The product may have subpotent hydrocortisone levels, but it is not unsafe to use. The recall is for potential ineffectiveness, not immediate harm.
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Where this comes from
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.
- Official source: FDA Recall #D-0480-2026 (March 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0480-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.