Hydroxycut Recall after FDA Warning to Stop Using the Diet Pill

hydroxycutFollowing the death of a 19-year-old male and 23 reports of liver damage, the FDA has stepped in to warn consumers to discontinue use of the popular diet pill Hydroxycut. Hydroxycut manufacturer Iovate Health Sciences has agreed to recall 14 products from the market as “an abundance of caution.”

From the FDA press release — The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The teen’s death happened in 2024, and was only reported to the FDA in March 2024. Dr. Linda Katz of the FDA’s food and nutrition division said it has taken so long to bring this to the public’s attention because the cases were rare and the FDA has no authority over supplements (a government report in March 2024 called for higher supervision of supplements by the FDA). “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” she said.

The FDA does not regulate supplements with the same authority it does pharmaceuticals. Producers do not have to have an FDA approval nor inspection of the products for safety or efficacy before being sold to consumers. “You really have to be careful about dietary supplements, especially weight-loss pills,” said Ano Lobb, who has studied Hydroxycut for Consumer Reports. “People believe that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims — that’s generally what they are.”

The FDA does monitor aftermarket reports for health problems related to these supplements. A similar warning in 2004 regarding ephedra forced the government to enact a ban on the supplement ingredient following reports of heart attack and stroke.

This list of Hydroxycut products being recalled include:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut Cleanse and Hoodia products are not affected by the recall.

“The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts,” per the FDA press release.

via FDA and Associated Press

69 Responses to Hydroxycut Recall after FDA Warning to Stop Using the Diet Pill

Denise says:

I used the 7 day clense it said it was maker of hydroxcut..Said to take 10 pills a day 5 before lunch and 5 before dinner..Well I did 20 pills within three days..and now I am worried I got bloated and was not using the bathroom often so now there was a recall on it tonight..Is that the regular hydroxcut or the 7 day clense? I’m confused..If someone could let me know..whoul appreciate it.Thanks

Brandi says:

Denise – according to the FDA press release shared above the “Hydroxycut Cleanse” was not part of the recall. Check with your doctor or the FDA site before continuing use though.

A. W. says:

So, if we own a hydroxycut product on the recall, can we return it like you would any other product? or were we screwed out of 30 dollars??

James Groom says:

I have been taking this for at least three years off and on. For the last 5 months on an everyday basis. I think that maybe that the people that are having issues like I have started having should get some sort of compensation. I have 4 children and just recently got married and if something happens to me, I know a lot of lawyers and kicking ass legally is not something I am afraid to due.

Christine says:

I just bought the drink packets and now there are recalling them.Can I go back to the store and get my money back?

Craig says:

James, you are the epitome of whats wrong with our society. If you haven’t had a problem yet then quit complaining.

Michael says:

I have been taking hydroxycut for 2 1/2 days, for a total of 25 pills ingested. It has been 24 hours since I took it last. Over the past 24 hours I have experienced stomach aches and pains, in addition to diarrhea. Should I seek medical attention or is this common when you first take it.

Anonymous says:

Hey, you were only supposed to take 3 a day for first 7-10 days!

kevin says:

i’ve been using hydroxycut for 3 months and even used those powdered packs. i’ve been having a little pain in the lower back and other things. is there something i should worry about?

I have the bottle of 170 Rapid release caplets which have been
recalled. Can I get my money back?

I have been taking the product for 3 months and just was diagnosed jaundice . My physcian is running more test and I have an appointment Monday May5,2009. I have contacted a lawyer to find out what my options are.

Mark says:

Here is my thing. There are a lot of products out on the market today similar to these hydroxycut products. Honestly I know that when I am taking any supplement that I am jeopardizing my health. I’ve never understood how America could let GNC, Wal-mart, or any other retail store sell products such as these, and they not be FDA approved. Are all the other manufacturer’s going to step up, and pull all the hydroxcut copycats off the shelf now?

Brett says:

I’ve used Hydroxycut & Hydroxycut Hardcore on and off for over two years without any issues. Maybe some of these affected people have other health issues or their genetic make-up leaves them prone for liver issues. My heart goes out to anyone who gets injured trying to better their own health. It is time for government regulation of supplements, the amount of money we pay for these products should help ensure their safety, not tax-payer dollars.

Cory says:

James, on the bottle it says don’t take longer than 8 weeks if you have been taking it everyday for five months and develope problems thats your fault for not following the directions.

Mike says:

There are many natural supplements on the market that people have been using for years with no danger to their health.
If the government regulates natural supplements, they will only be sold by large pharmaceutical companies that spend millions of dollars researching the affects. YOU will be charged for the research and good natural products will not be avialable to you. People should use their brains and a little common sense when buying and ingesting ANYTHING.
“If it sounds too good to be true, it probably is.”

Bo says:

I have used Hydroxycut off and on over the last three years and have had ZERO side effects except for weight loss and a lot of extra energy. I think the people who have had bad side effects are because of neglection. You cant just take the pills and sit on your rear end and shove twinkies down their throat and drown that down with soda. Some one should investigate wether or not the bad effects was because they did not follow directions on the bottle. Exercise, good food diet and lots of water along with Hydroxycut works just fine. If your not exercising dont take it. your waisting your time and ruining a great products reputation. Im still a faithfull user and will be until i run out. HARDCORE!!


Brenda Proctor says:

Where do I get my money back for the unused pills?
I am on my third bottle of pills. Do I need to go to the doctor? Please advise.

Power Lifter says:

I have been taking this product for years and have not had a problem with any medical problems. I’m a diabetic since the age of 5 and I have my blood checked all the time seeing I’m in the Navy. There has never been an issue with my liver. I’m not saying “keep using the product”…I’m just saying that we kill 10,000 – 30,000 people a day with smoking…and they haven’t banned that?…and that is EVERY DAY~! You need to make sure you are in good health and you do not abuse the product…

Wayne Soeder says:

How do we get a refund?

Blanca says:

I have used Hydroxycut for quite some time now. I could only get to the two pill amount because the three pill made my stomach hurt. I have gone from almost a size 16 to a 12 in about three months. I also stopped taking it two times a day and would only take two pills in the morning. I had lots of energy and could feel my weight coming off. I did however like Kevin begin to get mild back pain that felt strange and when I stopped using the pills I got much better so It was more common sense that made me stop taking them. The remainder of the bottle I will take to GNC and see what happens then I will stop drinking so much soda and stick to a low sugar diet.

joni says:

how can i get my money back?

Joe says:

Has anyone heard of any incidents from Twinlab’s Ripped Fuel? It’s a supplement that performs a similar function. I’ve been taking it on and off for the past four years. I haven’t had any problems, but I worry that it may be a slowly building up deterioration. Thanks in advance.

Earl Sewell says:

Wow, I’m glad I ran across this because I just started taking the Hardcore and noticed adominal pains and muscle cramps. I’m glad I stopped taking it.


Ive Used This Product For 3 Years Never Had A Problem But Get in The Best Shape Of My Life Some People Abuse Products Hydoxcut Has Been Out For Years Now These So Called Problems Arise

Hunter Perry says:

I bet that people that have the health problems with this product abuse it. You get what you ask for. It’s like any medicine you abuse. They need to run tests. 1 death is nothing the kid probably didn’t know what he was doing.

jimmy says:

HOW DO YOU GET A REFUND….DOES ANYONE KNOW…I HAVE SEEN THE QUESTION POSTED AND NO ONE ANSWERS. Also, I am curious about the people with the liver problems. My question is how much did they take. We know people overdose on things. I am curious if they took like 30 tabs a day or something. Not uncommon for people to have disorders and want to lose weight fast. Look at what people do with tylenol. Some take 12-15 pills a day of that. Just curious though, if they followed directions or got out of control..But, I am sure they will say they followed the directions….Don’t want to screw up the lawsuit.

Brandi says:

Refunds will vary depending where and from whom you purchased the product. We encourage you to contact the retailer from which you bought Hydroxycut to request a refund.

Becky says:

I was taking something similar and started having really bad diarrhea and could not stop. I went to the doc and got some medicine for that and they took a blood specimen and my liver enzymes were high and I have an appointment with a liver specialist. Scary stuff.

Lori says:

I think there are alot of ignorant people on here if you ask me. I bought Hydroxycut about 3 months ago, and I only took it for 3 days and got very sick. I exercise everyday, including running and the gym, I took it exactly the way the bottle said to, and I got very ill with extreme back pain. I’ve been that way since and my DR can’t figure out whats wrong. I recently found out that this product was recalled so I’m sure this product caused my problems because I was fine till I took it. Now that it has been recalled my DR is running more test.

Consumer123 says:

I used Hydroxycut for about 3 months. It was not until I noticed that it was no longer on the shelves that it had been recalled. Overall, I was satisfied with results, and the boost of energy. However, If this HAS caused any damage, is this something that will repair in a timely manner? I am still keeping up my exercising and good eating habits, I am just worried about my organs. =) Any advice would be appreciative. Thanks.

Clay Coey says:

I have been taking Hydroxycut for 3 years and it is the BEST workout/diet pill I have ever tried. Having ‘plateaued” on Zantrex, Hydroxycut Hardcore was the next logical step in the workout pill process.
I have never had any side effects from it, and I think many of these ‘problems” stem from people who simply cannot READ. The same people who ruined the reputation of Ephedra (the BEST thing ever for weight loss and work outs) are now the same ones who have runied it for Hydroxycut. DRINK WATER…DON’T DOWN THE WHOLE BOTTLE AT ONE TIME…EXERCISE…and STOP TAKING IF YOU FEEL ANY SIDE EFFECTS. DUH! How hard is this to understand?
I am sad to see it go, as now we are stuck with the “also rans” that don’t put the “pep in the step” we need when working out, and now we have to wait around until the FDA approves something else with the same ingredients and a different name to be produced.
Read the labels people.

Barb says:

I used to take the Hydroxycut with Ephedra back in 2001-2002. In early 2003 I was hospitalized for 3 weeks to have a benign but bleeding tumor removed from my liver. My doctors were baffled because that kind of tumor is associated with hormone usage, and I had never taken hormones. I didn’t tell them about the Hydroxycut because I was embarrassed to be taking it because I really only had some vanity weight to lose, and at that time there was no association with liver ailments, but I did have a feeling that it might be responsible and stopped using it. I guess my hunches were right.

wes says:

There is no short cut to losing weight but consuming less calories than burn. I’ve lost 12 pounds in the last 3 months the old fashion way busting my arse.

americanworker says:

Sounds like the new American way. People want to blame somebody and try to get something for free. Maybe I will go and spill hot coffee in my lap. Sound familiar. It’s got to end sometime.

Britt says:

To get a refund take the bottle (with remaining pills) to the store of purchase. Most stores say that the bottle can be empty or even just have 1 pill remaining and they will refund you. I know that GNC has the conditions of offering a full refund as long as the product not being expired, and was purchased within one year with proof of purchase by either bank statement or receipt.

Iovate Healthcare has also made a statement that if there are any problems returning any Hydroxycut products that they will offer you a full refund. Call the number on the side of the bottle for more information.

Terry says:

I think no matter how anyone looks at this drug , it is a warning and should not be taken lightly, your health is important and one should not rely on a drug that is potentially harmfull to one self no matter if you having symptoms of side effects or not.

Kristen says:

Just a side note to the previous posts.

1. They took these items off the market voluntarily to run further investigations. As of right not, nothing is certain and there is only a simple association between the reported cases and the medications.

2. Once damage has been done to your liver, it cannot heal itself. The damage is permanent and unrepairable. There is nothing you can do about it, that is, other than transplants.

3. Whether or not the drug was abused, rules were not followed, or it was used as directed has yet to be distinguished.

Dan says:

I have been taking Hydroxycut off and on for close to 8 years now. I follow the directions and have had zero problems from Hydroxycut. I noticed several people mentioned back pain, if Hydroxycut was affecting your Kidneys you would have back pain. When the liver is involved 99.9% of pain felt is on your side and just under your lowest ribs. I think that alot of people are now falling into the “Self fullfilling prophecy” since hydroxycut has a recal pains, diareha, constipation and who knows what else are going to be attributed to it. All of you talking about litigation, if you read the label you would know that you took hydroxycut at YOUR OWN RISK.

Lyle says:

this is not a product to fool with, It works to a point and you do need to read the lable CAREFULY and understand it.
I took it for about 3 months and I was a healthy active in shape person I did not like what it was doing to me I lost the inches but it had side offects as well. I have no history of illness in my family what so ever. shortly after stoppng the hydoxycut I had a massive heart attack and during the recovery of the attack they do blood work lots of it. They found now that my liver is damaged and headded for a crash I have lost my lung capacity to breath because of the heart attack (not to mention the mental stess i have now) I am unable to do the things i used to do because i have no energy and i tire very fast (new life now). I am looking at legal action I did follow the directions and even cut back the amounts because i am not over wieght just had a love handle that I wanted to get rid of .
NOW I HAVE A DIFFERENT LIFE STYLE AND A DIFFERENT OUTLOOK ON LIFE >>> if it is to good to be true it is just that (not true) and the people in the heath food stores should be sure of the produces be for recomending them…But who guides them ?

brennalynn says:

Hi, jimmy . just take the bottle back to what ever store you got the pills ,thay will honer your refund ,even without your receipt.
its a recall from the F. D. A 🙂 brennalynn

Kain says:

Ive been taking the hardcore since January and ive been running everyday. Ive lost 50 pounds and feel great. you have to drink a lot of water a day to keep in good health. everyone that has had problems probably doesn;t drink enough. Anyone who has a bottle and stopped taking it should send it to me cause i would like some more cause i ran out. Im now taking xenidrine which is basically the exact same.

Kain says:

P.s. Lyle
It may have been coincidence about your heart attack and stuff. Im sorry your hurt but sometimes things happen and it may have nothing to do with the pills.

Tomas says:

I wold like to know the real difference between Hydroxycut and xenidrine, since at first I was really interested in Hydroxycut, but now with this recall, it has made think twice. And how safe is Xenidrine. Thanks

Val says:

I’ve been taking hydroxycut for years. I lost about 25 pounds. I’m not jumping to conclusions, but just wonderin if anyone else has had dark areas on their skin while taking this. My whole chin has turnd very dark. It use to go and come, but it hasn’t gone away for a few months now. Just curious!

Bombero says:

Is HYDROXYCUT Weight-Loss Formula in this group? I purchased a few bottles a while back and havn’t finished them.
I agree with some people that if you abuse it it will give you problems.

Refunds R Us. says:

I work at a Vitamin Store. Hydroxy Cut can Have adverse reactions. On any Diet Supplement I suggest all and i mean ALL customers to start out on half doses to see how their body adjusts to it. If it works goo, then take full dose, If theres a Problem, then cease the Dose.

As for returns, Get your receipt and bring it back to the shop you got it to. The Company has to accept the return aslong as the purchase was in 30-90 days depending on the company.

As for Intestinal Problems, Wait 2-3 days, Drink lots of water, And Get some nice Digestive Enzymes and that will work out your Kinks. If it doesn’t, Seek a Physician. As for Lower Back Pain, That could be Due to your work out, Hydroxy cut is effecting the liver and blood flow. No real reports of back Injury due to Product.

Again, Take your Reciepts and Visit your Local Herbal/Supplement/Vitamin/GNC type shop, and Get your Money back.

This recall sheds light on just some of the tremendous dangers associated with the desire to change ones body through a “quick fix” via a pill. What some people may not realize is you do not have to abuse supplements like these to become a victim of their harmful side effects. There were reports of liver damage from individuals who took the recommended dose on the label. The Center For Eating Disorders has posted their response with a few of the many dangers associated pills like these and pose the question Is the risk really worth it? We’d love to hear your thoughts.

Henry says:

Where do you return the product if it was given as a gift? I do not know where it was purchased at, and when I called the number on the bottle it directs me to the website hydroxycutinformation.com which does not answer my question.

dave says:

Ive been using hydruxicut, this product was good, i think people were not taking the recomended dosage…it always happens like this, the problem is the people who take it, not the product.

And stupid america… is like that al the time… can iget my money back? dudes cmn…. u already bought it.

tw says:

hunter perry!!!, you die and see if your missed!!! 1 death is something! everybody should be worried. nobody is above dying! if you’ve been taking it for years then great! keep taking it. for those who are cautious.. good! weight is a big thing and it sucks going at it alone! if you don’t have the money like most don’t and need help without going to a dr. try counting calories! take your weight and x’s it by 11 then minus 500. that should be the calories you take in to lose weight. if you want to maintain then your weight x’s 11 is what you need to eat to maintain. these pills make you fill full and that is all its doing the rest is up to you to stop eating and exercise! good luck to all and i hope your in good health!!! i’m no professional but this method works for me!

tammy says:

How many of the people reporting problems had pre existing medical conditions. known or unknown. I took hydroxycut max and it worked great and never had any probs. it’s just like when they recalled phen-phen. the people who had heart valve problems and heart attacks were overweight and already had compromised heart health. the bottle talls you to start on 1 pill and work your way up to 3 pills for a reason. to see how your body will react to it. The fda did the same thing with kava kava a couple of years ago because they said it caused liver damage. I took that for years too. I just had my physical and my liver is fine after taking hydroxycut and kava kava.

jaymee says:

this really stinks! I just found this product a few months ago..luckily i didnt take as prescribed, because I couldnt, my stomach cramped, i felt back pain and had slight symptoms of heart attack in nature. I am a healthy 34 yr. old woman, I truly thought that when they recalled this it was due to someone abusing it, I now realize I was wrong. What I did do was listen to my body though, and reduced it to just one a day or used it when I needed energy for work. I feel strongly that energy or vanity is NOT worth takin this drink! If you have had no side effects yet it is completely insane to continue to take this product until it does effect you and potentially altar the quality of your life forever.

tammy says:

maybe some people are confusing caffine overdose with heart attach symptoms. on the bottle it says ” be sure not to drink anything containing caffine such as coffee, soda or tea. Drink plenty of water. Dehydration can cause stomach cramps, severe headachs and the feelling that you need to go poop.

ashley says:

I have taken hydroxycut for like 3 years of and on and i have no problems….does this mean i should quit taking it???? I have spent alot of money on the products as well am i going to get the money back that i spent because all the pills and drink packets “on recall”…

Leslie says:

I have taken this product for over 4 years now on and off maybe longer, and yes i have had my liver enzymes come back critically high at least 3 times and the doctors could not give me an answer to as to why . Since the recall I am speaking w/ my doctors to see if this is the cause. I have yellowing of the eyes, jaundice, elevated liver enzmyes, and i have a lot of right sided pain. If you are taking this product or any other diet product stop.

Jenn says:

I took Hydroxycut for only a few weeks, and the week after I stopped my entire body was sore. It was excruciating pain to try to sit up, reach for something, or even squeeze my hands. I couldn’t move or anything for that whole week, til I went to the doctor and got steriods. And even then, They couldn’t figure out what was wrong.

Jessica says:

Ive been taking the hydroxycut rapid release pills for about a month now and finished off a bottle, I’ve had no pains or any issues with it.
Does that mean I’m okay, or will I have any health issues in the near future due to the product?

kaiser says:

Why take a product that increases your heartrate?

ANITA says:

i was taking the pills for a bit but i stoped due to seizure cativity wtf now the dmv has pulled my drivers licenes i cant drive i have to lil boys to take care of i am gunna sue!!!!!!!!dont take the pills

Anthony says:

I have been taking Hardcore for a while now, off and on. I have lost about 25 lbs. I really love the product, but did have some of the side effects. Will I have to worry about my health in the future?

jason says:

To James Groom….You are a complete and total moron. Who takes the stuff for THREE YEARS!!? You obviously didn’t read the label and directions for use. My guess is that you are just another grossly overweight person who is too lazy to lose weight the RIGHT way, so you pop these pills hoping for the easy way out. That is how people get messed up on this stuff. Learn to read, then do some research, and quit lookin for a lawsuit for your own stupidity. And most of all, if you’re going to leave comments, learn to spell!

kimber says:

I’ve been using Hydroxycut for over 15 years. I even used it when it still contained Ephedra. And I’ve never, yes, never had an issue. My liver enzymes were never elevated. But then again, I didn’t take 12 pills a day. I excercised and ate right and didn’t depend on just taking a hand full of pills to loose weight. Everyone’s metabolism is different, and everyone’s chemical composition is different. Diabetics can eat sugar, but since I’m not diabetic, I can. Some people are allergic to antibiotics or codine, others are not. So just because a few people have had a reaction to the ingredients in Hydroxycut, don’t freak out and assume your aches and pains are because you took it. If you look at the ingredients, you’ll see that it has the same things as cofee and multivitamins, just alot more of it. As with all things, just avoid excess and realize there’s no magic weight loss pill, you still have to excercise!

Brett says:

I have tried Hydroxycut in the past with zero results. The only supplements that worked were the ephedra based products or Clenbuterol which are now banned. I have used both drugs in the past with stellar results. Yes, they are known to cause health problems IF you do not use them correctly. Due to the people who don’t like to listen to the warnings on the labels and think the more they take the faster they will lose weight, we lost two excellent products. Now, we are stuck with drugs like Hydroyxcut that do not work and STILL leave you at risk of health problems.

eric says:

ive been using hydroxycut for atleast 3 years on and off
i use it when im in my “cut” cycle and dont use it when im in my “bulk” cycle
ive had great results
ive never had any of the side effects people mentioned
but ive never been to the doctor to check out my liver
too bad stupid people have to mess things up for the people who like the product

Kerry says:

I’ve been using Hydroxycut off and on for the last 6 to 7 years and I’ve never had any negative side effects. It goes back to common sense….don’t abuse anything ie. hydroxycut, tylenol, asprin, etc. and there might be minimum side effects if any. If you are noticing any problems then stop using it! Not everything is made for everyone. People need to take responsibility of their actions and shouldn’t try get money because they are not in tune with their body. Millions of people have taken Hydroxycut and it is one of the best selling supplements ever. But since there’s a death and some liver damage, it’s Muscle Tech’s fault. What a joke. I think the ratio of positive productivity to negative side effect is huge. Nobody ever complains about losing weight!

Lady Jaz says:

I stopped taking Hydroxycut after about 6 months. I was always jittery and restless. I didn’t sleep well. Now I am experiencing muscle cramps and weirdness in my nervous system.

lell says:

I agree with those who have posted their comments about people wanting Hydroxycut to be the miracle slimming pill. Many overdose on it think it would work faster. The sad truth is we have become an instant society. This only shows how gullible we are to fall for products that promise us instant gratification and we then pay the price for it (wealth and health)

jay says:

i’ve taken hydroxy cut off and on since 06 and now in 09 im having seizures and probably liver damage…i go see a sleep study doctor 2morrow if they rule out sleeping disorder it’s definitely them damn hydroxycut pills…they work but they kill ya

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