ThermaCare Recall: Heatwraps May Leak, Burn Skin

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Pfizer has issued a recall for one lot of ThermaCare HeatWraps Menstrual products due to a risk that they could leak and cause serious skin injuries and burns. 

The ThermaCare HeatWrap recall was announced on September 24 by FDA and Pfizer. The lot was distributed in the U.S. and Puerto Rico.

ThermaCare HeatWraps are wraps that are used to provide heat therapy to sore and aching parts of the body. They contain a number of cells that include ingredients that generate heat when exposed to air. The heat cells are enclosed within the wraps to keep them away from the skin. The Menstrual wraps are used to treat menstrual cramping.

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The recall affects all ThermaCare HeatWraps Menstrual products with the lot number of E06831 and an expiration date of 8/2012. The lot number may be followed by an S or an N. It is listed on the outer carton and the foil pouch containing the wrap.

Althought there have been no reported injuries connected to the heat wraps, Pfizer indicates that they have the potential to leak components directly onto the skin, which could cause skin injuries including irritation and burns. Each heat cell contains a mixture of activated carbon, iron powder, sodium chloride, sodium thiosulfate, sodium polyacrylate and water.

Pfizer is asking consumers who have purchased the heat wraps to throw them away and record the lot number, and call 1-800-323-3383 for a replacement product. The FDA is asking anyone who believes they have been injured by a ThermaCare HeatWrap Menstrual product to contact the FDA MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

Tags: Burn, Defective Product, Pfizer, Product Recall

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18 Comments

Shannon
I bought the thermacare heat wraps and wore one for about 6 hours for back pain. I started to feel it really burning and took it off and I had 3 huge blisters on my back. For the first week I was severely out of it. I slept for about 6 days until a family member came over and looked at it and took pictures to send to my dr. One of the blisters was like burrowing into my back. I had to take antibiotics and cream for about 10 days and it took a couple of months to heal and is still not healed a 100%. I will be scared for life.
Cassia
I wore the back wrap thermacare heat wrap for about 20 minutes and I have blisters across my back, and under my breasts where the Velcro and plain (non-heat) wrap strap was also has welts. The welts itch but the blisters hurt so badly, causing nerve pain. It’s terrible!!
Kristina
I started using Thermacare heat wraps 1 month ago for back pain. I used them for only 8 hours a day like the packaging said and what my doctor told me. As time went on I was using them everyday because they seemed to help with my back pain. In the last week I noticed my back pain was getting worse and I was having a lot of pain and inflammation in my abdomen. My doctor has done tests and can’t find anything wrong for me to be having all this pain and inflammation. When I put on a wrap today it was burning my back. I took it off and looked at my back in the mirror. I have burns all over my back!!! Are you kidding me?!!! I used these wraps as directed and even asked my doctor about them before I started using them. AND THEY STILL BURNT ME!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! I’m going to my doctor to document everything so I will have a very strong case against the makers of Therma heat wraps.
Sandra
I have not used the wraps. Stupid me, I bought 4 tubes of the cream. Bad. I have been using the cream for about 2-3 weeks now. I told myself on 4/18/20 that I must give my legs and upper arms a break from this cream since it burns so bad. I never thought that on or around 4/1 or so that this product would burn so bad. Do not buy it. I used other products like this and it doesn’t sting for days after using it. I mean I will rub behind my knees, and then 5 hours later ? My shins are burning. How is that? 2 weeks ago I put cream on my bicep. And 12 hours later my hip was burning? I’m throwing all 4 bottles of cream away. I can never use this again and I hope I don’t have nerve damange from this product. I have used it on my lower back, my legs and arms since I was hired (due to Covid) to clean up Amazon and their tables, lunchrooms and warehouse hand washing stations. I had severe overuse injury from walking non stop for 7.5 hours. Unless on 2 15 min breaks and 30 min lunch. Other than that, I had bad hip, knee and ankle pain. I had horrible shoulder pain from repetitive use of it for 1 month. But this burning? Oh man. The burning on my skin is a 50 on a scale of 1-10. The overuse injury was painful, but not this bad. do not purchase anything from Thermacare. It’s bad.
raya
I applied thermacare heat wrap on my back for relief of a muscle pain. After removing the wrap, I had burning pain in my back and under my breasts where the heat wrap is attached by velcro. The burning pain is unbearable, especially undertone breasts. Have tried ice packs, Bipanthen cream luke water shower but the pain is increasing. on examination, there is no external signs of burns, the skin appears completely normal. Could someone help urgently, please!!! It seems to be an allergy, but I need help to reduce the burning pain!!!
Robin
I have read the comments above from as far back as 2014…where there are serious skin injuries from the Thermacare products. Why have they not been removed from the market? I recently bought a Thermacare patch and after 2 hours I had to remove it because the burning became intolerable. Thankfully there was no blistering but the area and beyond was beet red and painful, itchy and numb with occasional prickly nerve sensations. And 10 days later the area is still numb. My concern is that there is also damage to the tissue beneath the skin… What can be expected? Will this numbness go away?
Bruce
I was wearing a lower back thermacare wrap and I suffered 3 3rd degree burns, still healing but very sore and angry about the failure of this product.
Julie
I used a Thermacare patch specifically for mestrual relief. I left the patch on for 6 hours as the box instructs. When I took the patch off there are 3 spots on my lower abdomen with severe burns and skin had been taken off. I could not work or put on pants for 2 days due to the extreme pain. I didn’t initially take pictures but I have taken them now but it is 6 days later and it is still extremely painful and doesn’t seem to be healing well.
Dianne
I too have been using these thermacare heat pads for my back and I wore it for the eight hours yesterday and woke up with a big blister on my back! I was told to use triple antibiotic ointment, not sure if it will heal or not. I have used these for years and never had this problem before. I wear it over my under garments I guess the heat or chemicals whatever is in those little stones burned through to the skin. I guess I need to find something to replace them for my back trouble! I do think they should remove them from the market it is (2014) I guess from what others said years ago while using them it happened also to them ! It hasn’t changed or improved from what they say on this site !!!!
Rache;
Allie, I still have nerve ending pain an not healed from the burns I sustained August 29, 2013, I have the same type wounds and blisters from the heat wrap. I have tried lots of things but noting is working. See the above comments I have posted earlier. Never had such pain from the blisters and nerve endings.
Allie
I got burned just yesterday by the back/hip wraps what should I do? I have a nickel sized open wound on my back. It hurts so bad.
Rachel
Update on the Burns I received Aug. 29, 2013 after I used the ThermaCare Heat Wrap. I am still having severe nerve ending pain and the burns have not healed as yet. I have been advised by my Physican that these are 2nd Degree Burns and Nerve Damage. Medications do not seem to reach the pain. tHIS IS DAY 55. THESE NEED TO BE REMOVED FROM THE MARKET.
rachel
Thurs., Aug 29,2013, I used the ThermaCare neck and shoulder pads on my lower right backside and right leg from my knee to hip for approximately 20 minutes at the most on each place and that evening had large welts which turned into blisters and sores all over my lower back and all around my leg from my knee to hip. Went to the DR. have been on medications since, severe pain, looks like 2nd degree burns. Called Pfizer, said because I used them on my back and leg would not do anything, even though the directions said they could be left on 8 hours and I only left them on 20 minutes at the most. I can see the exact size of the burned places on my skin from the wrap, so I WOULD RECOMMEND NOT TO USE THES WRAPS. It is now Sept 7 and I am still hurting and not healed..
Janice
I’ve been using the ThermaCare menstral heat pads for a couple of years. I usually wear them during the day at work when I have my period, for the full 8 hours. Today for the first time, when I got home I had blisters and red blotches on my abdomen. They are surprisingly painful and bright. I read that there have been problems with chemical burns from these. I was so surprised to find this! I’m only 27, so the age 55 warning doesn’t apply. I also threw away the packaging at the office and know it’ll have been taken out by the time I get in tomorrow. They should really revamp the product since it sounds like this happens frequently to women of all ages.
Patricia Krossa
I have used Therma Care Heatwraps many times. I have never had a problem with heat burns etc. I use mostly during cold weather times. They are very good to help pain during cold weather times. Can I look foward to puting Thermacare back on the market. Thank You.
Jeanne
Just like Karyne, i used one of these patches last week (for 4 hours) and got a huge blister on my abdomen. The blister is now really gross; it’s oozing and the surrounding area is beet red. I’m concerned that it may have gotten infected. I called the store where it was purchased, and they have entirely different lot numbers on their current stock. Unfortunately, i don’t have the box anymore…who knew I would end up needing it? Anyway, I hope this thing heals up. I’ll be seeing my doctor in a couple days if it doesn’t.
Karyne
Help! I just removed the pad a few minutes ago, i had used it for 7 hours on my lower abdomen. I have a large blister from a burn. What do I do now?
Kathleen
I have welts and open sores on my back from the Thermacare back pain patch. I wore this patch 3 days ago and my back is still sore from the burns. What am I to do? thank you.

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