Edge Pharma Profound Dental Gel Recall: CGMP Deviations Risk

Take action

Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Edge Pharma is recalling a dental gel product due to manufacturing quality control issues. This recall does not involve immediate safety risks but requires consumers to check their product's batch dates and contact the manufacturer for further instructions.

Why it’s dangerous

The product was manufactured under conditions that did not meet current good manufacturing practices (CGMP). This means the gel may not be as safe or effective as it should be, but it does not pose an immediate risk of injury or illness.

Who’s affected

People who purchased the Profound Dental Gel with NDC 05446-0407-10 between September 2021 and April 2022 are affected. Dental patients using this product are most at risk.

How to tell if you have this one

Check the product label for the NDC code 05446-0407-10. The gel was sold between September 2021 and April 2022. The product is for topical oral use.

Brand
Edge Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC code 05446-0407-10 on the container.
Contact Manufacturer
Reach out to Edge Pharma at 856 Hercules Dr., Colchester, VT for further instructions.

✎ GovInfoNow

Questions people ask

Is this product dangerous to use?

The recall is due to manufacturing quality control issues, not an immediate safety risk. The product is safe to use but should be checked for the NDC code.

When was this product sold?

The product was sold between September 2021 and April 2022.

How do I know if I have the recalled product?

Check the product label for the NDC code 05446-0407-10. The gel was sold between September 2021 and April 2022.

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-0440-2022 — Edge Pharma Edge Pharma

Hello,

I own a Edge Pharma that is covered by recall D-0440-2022 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0440-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0440-2022 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 Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose

Lower-risk recall