Edge Pharma Profound-PE Dental Gel Recall: CGMP Deviations

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Recalling firmEdge Pharma, LLC856 Hercules Dr · Colchester, VT 05446-8014

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Edge Pharma is recalling Profound-PE Dental Gel products that were manufactured between August and December 2021 due to CGMP deviations. This means the gel may not meet quality standards, though the specific risk is not detailed in the recall notice.

Why it’s dangerous

CGMP deviations refer to failures in the manufacturing process that could affect product quality. While the recall states this, the specific hazard mechanism (e.g., contamination, incorrect dosage) is not clearly described in the notice.

Who’s affected

Dentists and dental patients who used the recalled Profound-PE Dental Gel products between August 2021 and December 2021 are likely affected. Patients using the gel for dental procedures are at higher risk due to potential quality issues.

How to tell if you have this one

Check for the product name 'Profound-PE Dental Gel' with the NDC code 05446-0408-10. Products were sold between August 2021 and December 2021 and are available in 30-gram jars with a spear-peppermint flavor.

Brand
Edge Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the NDC code 05446-0408-10 and the date range of manufacture (August 2021 to December 2021).

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The recall notice does not specify any remedy.

What is the specific hazard with this product?

The recall states CGMP deviations, but the exact hazard mechanism (e.g., contamination, incorrect dosage) is not clearly described.

When were these products sold?

Products were sold between August 2021 and December 2021.

Take action

Contact Edge Pharma

We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0442-2022 — Edge Pharma Edge Pharma

Hello,

I own a Edge Pharma that is covered by recall D-0442-2022 from Edge Pharma.

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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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-0442-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0442-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Edge Pharma, LLC recalls Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%,

Recall notice