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Dermatend Mole Remover Recall Issued Due to Safety Concerns

  • Written by: Russell Maas
  • 33 Comments

Federal safety officials have forced a recall for Dermatend mole remover products, indicating that they have never been shown to be safe or effective, and promotion of the at-home treatments raise safety concerns, since they may delay diagnosis of serious conditions, such as cancer.  

A Dermatend Original and Ultra recall was announced by the FDA on August 28, indicating that the manufacturer never obtained the agency’s approval to sell the products promoted over-the-counter for use to remove moles, warts, and skin tags.

In a statement issued by the FDA, the health regulators indicated that moles should only be removed under the supervision of a dermatologist. The agency also warns that the use of Dermatend or other over-the-counter products may cause delays in seeking medical attention for suspicious skin developments, which may be early symptoms of serious medical conditions such as cancer.

The products being recalled are Dermatend Original and Dermatend Ultra products sold in all sizes and dosage forms at the distributor and wholesale levels. The products were packaged and sold in flexible plastic tubes labeled with instructions on how to apply the treatments to remove warts, moles, and skin tags. The plastic tubes also have the product name printed across the front in blue letters.

Dermatend products were manufactured by Solace International, Inc. of Reno, Nevada, where they were sold nationwide at the wholesale and distributor level for around $30. Solace International is notifying its distributors by certified letter and arranging for the return of all recalled products.

The FDA warns that consumers who purchased Dermatend Original or Ultra to remove mole, warts, or skin tags should immediately discontinue using the products and consults their healthcare physician. Customers with questions regarding the recall should contact Solace International at 775-323-1413 or email them at info@dermatend.com.

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33 comments

  1. Bohyeon Reply

    I have dark brown spot on my face since I used it.
    It`s been four months that I have those ugly dark spot on my face.
    I can`t go out without heavy make up.
    It`s not just mentally stressed out, totally F***up my face..

  2. Angry Reply

    It Angers me the FDA recalled this product. it worked exactly as promised. I wanted to buy more from amazon because the first batch worked so well. I come to find out the product was banned. Yes, if you dont follow the instructions exactly you can hurt your self. I am sick of the nanny state protecting morons who can’t read. I want this product back.

  3. Elaine Reply

    Well, that figures. I came looking for this product because several friends highly recommended it. The fact that the FDA recalled it tells me that it worked too well and made Big Pharma so nervous that they forced a recall. Gotta love the way it’s all about the money, when it should be about finding products that actually work. Someone needs to recall the FDA.

  4. Kimberly Reply

    I used this product on several moles that my dermatologist said were fine (not cancerous). One of the moles was a very large mole on my ear that my dermatologist said would cost thousands of dollars in surgery to remove and would leave a scar. Dermatend removed it with no problem and left no scar whatsoever.

    I still have my tube left, but I am disappointed that this is happening. You should always see your dermatologist regularly, you should be able to get this by prescription at least.

  5. carol Reply

    I used this product on a very small mole on my calf. It was tiny but potruding. The mole has swollen into something huge and I havet had it for over three months and it looks very ugly. The doctor was shocked. I think it is a risky product which can have negative results I wish I had not used it now so it is best it is banned.

  6. Rachel Reply

    I’m disappointed that this product has been recalled. I have used it before on 3 benign moles which it removed perfectly with no scarring. I agree with the above comments: if it wasn’t so successful, it wouldn’t have been recalled. There is a whole lot of snake oil being sold that is useless and allowed to continue because it doesn’t threaten the established industries.

  7. Kristyn Reply

    I’ve used and liked this product as well and only stumbled on the recall because I was trying to reorder! It was effective and way cheaper than having dermatologist remove. I agree with Elaine, it’ll be back on the market soon ….as prescription only!

  8. brandon Reply

    This is highly disappointing. This product works exactly as advertised. The fda will pull anything off the shelves that they dont have their hands in. They are all about the money in bed with big pharma. I only know about the recall because I was online looking to buy more

  9. Rachel Reply

    Dermatend works, and that’s why it’s being recalled. The FDA is truly reprehensible.

  10. Kenny Reply

    I have been searching for days to find something like this and finally I found something with 99% great reviews but once I go to find out where its sold I see its bin recalled, wtf

  11. Michelle Reply

    I used this product and it worked just like it said. It left no marks or caused “swelling” to any mole or skin tag I applied it to. I first had what I wanted removed looked at by my dermatologist and all were safe to get rid of. I like many others just finding out about the recall because I want to purchase more. I wish I could but I still have a tube and have no fear of using it on a few skin tags. the FDA is out of control and wants control of the natural market as well. It’s so nice that only a “pharmaceutical drug” can cure, prevent or treat a disease anything else even if it is proven to work can’t claim to do any of these things because it’s not a pharmaceutical drug. This rule needs to be changed..

  12. Annoyed Reply

    Absolutely brilliant product. Was told by doctors to remove moles from face it would be classed as ‘plastic surgery’ costing thousands of pounds – I don’t have that kinda money to splash out on so called ‘plastic surgery’. I turned to Dermatend and it worked fantastically, i was 100% happy with the results and many months later I am still amazed at what it could do. The fact the product is made of a natural substance is great but that means the FDA hate the idea theyre losing out on money because this product is successful. Really disappointed to hear this news because I want other people to be as happy as me thanks to using this.

  13. ticked off Reply

    This product worked great! When you can actually read and understand the english language and follow instructions. This was a great product that did exactly what it claimed it would do. It’s a shame that whiny people who don’t follow directions, the FDA and overly wealthy pharmaceutical companies can ruin a good thing for so many people. This is proof that the money is in the treatment not the cure. Otherwise it would still be available. To the morons involved in the ban of a working product, Thanks for screwing it up idiots!

  14. Melody Reply

    I found this when trying to reorder. I’ve used Dermatend to remove skin tags, moles and even a peanut sized bump of scar tissue on my face left over from childhood chickenpox. It saved me thousands of dollars in ‘cosmetic surgery’ fees. There are many bigger issues that the FDA needs to be focusing on instead of taking a product that has saved people money and helped them feel better about themselves.

  15. Billy Reply

    just found out about this recall. Quite surprised actually as Dermatend actually worked for me. Got rid of a mole on my chest and lightened a mole on my cheek. I had some left but lost it somewhere in my house or maybe got through out. Was about to buy some more. Shame really

  16. Please bring it back Reply

    I can’t believe they recalled this product. I have used it on moles and it left no scarring as opposed to the three moles I had removed by my dermatologist that left me looking like Frankenstein!! This should at least be available by prescription from you derm. If you are getting regular skin checks there is no reason this product shouldn’t be available.

  17. What the? Reply

    I’m confused this product worked perfevtly. If some people had a bad reaction they probably have bad reactions to most. I removed moles on my face and neck it was the best. Bring it BACK…

  18. Cindy Reply

    If FDA is against it, it must be really good!! They have no interest in helping the people, only Big Pharma!!

  19. Sue Reply

    I’ve used this product for several years and it works great! I’m sure it was banned by the FDA due to pressure from doctors losing a couple hundred bucks a visit to remove moles using conventional methods that leave ugly scars. My last dermatology visit to remove questionable (but thankfully benign) moles cost me a $50 doctor visit, plus the copay of $139. The insurance company paid nothing, apparently because I received a “discount” from the dermatologist for having UHC. I’m going to keep searching for Dermatend, or a similar product!

  20. dale Reply

    A truly great product — and the ample size tube lasted for a long time, and it was so easy to apply. Just buff the mole and dab on some of this “black tar”, and in a few weeks the mole was gone. Good products are so hard to find and then when you do some a$$wipe recalls it.

  21. Karen Reply

    I used Dermatend on several moles. It worked fantastic !!!! I had to reapply it and do it several times but I loved this product. It removed a quite large raised mole that I had had for ever, and now it is flat. I have been trying to find some for my son and now find it has been pulled. I’m very disappointed because it worked wonderful.

  22. Mila Reply

    Why would they ban such a product ?!!! I was looking everywhere for this product for past two months now !!! So disappointing !!!!!!

  23. mallory Reply

    I’m so upset about this product being recalled. Not only did it remove my biggest insecurity between my eyes that was dermatologist approved, but it made me feel so much better about my face. I bought this 2 years ago, and lost the tube, & was wanting to buy a another one. I’m very upset. Fda this is dumb.

  24. Jen Reply

    For all of you who want another option, the main ingredient in Dermatend was Bloodwort, also called Bloodroot: http://www.earthclinic.com/remedies/bloodroot.html

    Just try to find it via some herbal resource, make it into a paste if it comes in powdered form, and remember to be careful and use it only as Dermatend directed. If you use it wrong, the results can be horrendous, since bloodwort eats away at the skin.

    I, too, came across this site when trying to get the same amazing product for a family member and am truly sad to see the FDA is recalling it. However, since I’m a stickler for learning about what ingredients are in the products I buy, I know the key ingredient in Dermatend and it was bloodwort. Pretty cool stuff — read about it on that link.

    For those of you who never had Dermatend, here’s what a Dermatend toolkit should comprise of:
    File (like a nail file)
    Toothpick sized stick (for application)
    Ointment (for the healing process)
    Gloves (to be safe — bloodwort DOES eat away at skin)

    What to do:
    1) Put on your protective gear! Gloves.
    2) Apply a warm/hot towel to the area you wish to treat. Allow it to soften, prep the skin.
    3) File the problem spot with the file in your kit — just enough to abrade the skin for the product to “infuse” better
    4) After making sure the bloodwort paste is thoroughly mixed in your container, use your toothpick or applying instrument to apply the bloodwort onto the affected and filed area — make sure it isn’t anywhere else. Let it sit on there for 30-45 minutes. It should tingle for 5-10 min.
    5) Remove excess with a cloth — do not leave product on skin.
    6) In 24 hours you should have a scab.
    7) After it scabs, then you apply the ointment to help the spot heal.

    If 1 go isn’t enough, there’s always the option of a round 2! Good luck!

  25. Mike Reply

    I am like so many others! Had a skin tag on my back and Dermatend removed it quickly and with no scar, and I used it on a few moles and same thing! The FDA is wrong in this case! Bring it back!

  26. Andrew Reply

    I have been left with a indented scar after using dermatend to remove a flat mole. If anyone can help me please call me at 714 414 2496. Please. I would greatly appreciate it

  27. Krislena Reply

    I saw this product in a magazine during a fly. I bought it as soon a got to my house. I had a ugly brown mole in my face for almost 15 years of my life. The dermatologist was charging me almost 1000 to removed it. I used this wonderful product to removed the mole it worked so great, I didn’t get any scarfs, I love the way my face looks now. I also removed 10 other friends mole they also were so happy. Shame on this people who got out such a wonderful product.

  28. John Reply

    I was also on line this evening trying to reorder Dematend which in both my and my wife’s opinions was an excellent product. It worked great on myself, so I used it to remove some moles from my wife’s face with excellent results. My wife’s skin looked like the moles were never there after I treated them with Dermatend. In contrast, her twin sister had a mole removed from her face by a dermatologist and it left a small indentation.

    I am absolutely disgusted with the FDA for pulling this product and with the nanny state mentality in general in our country. Just as I was thrilled to witness the fall of the former Soviet Union, I hope that I also live long enough to see the power of our federal government dramatically reduced.

    It was encouraging when the British people voted this year to peacefully separate from the EU. Hopefully our own populist movement will be successful in pulling power away from our corrupt establishment politicians (in both political parties), special interest groups and federal bureaucracies in Washington, D.C.

  29. Psychologist Reply

    A. I’ve tried freezing and acid type products and none of them failed to work for several–worst was the acid type with only produced a permanent acid/wound scar and freezing is unsuitable for skin issues too large or too small or irregular shape (where the skin site doesn’t fit the shape of the applicator)
    B. Dermatend skin tag remover actually works and is the only product I’ve tried that does.
    C. As far as I can tell the only reason the FDA threw their weight at this manufacture was that the AMA, i.e., their attorneys colluded with the FDA, i.e., those attorneys to screw over a company that actually made a product that works.
    D. Now that we have an better educated, level headed, less hate driven President in Trump, it seems more likely that the “government” will back out of areas that are of no concern to the federal (or state) agencies who’s only job, in the past, has been to harass the general public and put more bucks in the pockets of the politicians.
    E. Letters from customers to the new heads of these govt. agencies and the new president are likely to have different outcomes than solicitation to the previous batch of loosers.

  30. Psychologist too Reply

    Dermatend, I have learned from experience, actually works as advertise and does so in applications not suited for most other wart/tag removers. Moreover, the FDA’s purview, as it always has been in the past, is to test and render an opinion BEFORE it is sold to the public,not to sit on their fat asses and collect a paycheck and wait to see if someone catches them not doing their job.
    Further, since the US is Officially the worlds second dumbest country I can just imagine some third-world moron with cancer using Dermatend because they are stupid enough to think skin cancer is just a different kind of wart then get surprised that it was not intended to do that and get the attorney’s from AMA and from the FDA on this companies case out of pure stupidity.

  31. Khoi Reply

    No wonder why i can’t re buy Dermatend. This is why we voted for Trump. OVER regulation. Learn to read direction!!

  32. ankita Reply

    I want to buy this product

  33. ken Reply

    i used this 8 years a go it works that s y they dont want you to used it works well

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