Hylands Teething Tablets recalled because of belladonna toxicity

Monday, October 25th, 2010 By

Close-up of a teething baby's mouth.

Teething hurts. So does belladonna poisoning. (Photo: CC BY-SA/Daniel Schwen/Wikipedia)

Parents know that teething is a painful time for both their kids and themselves. Tablets that help soothe the gums can sometimes be the only thing that permits a good night’s sleep, making them a mainstay for well-prepared moms and dads. This is why the U.S. Food and Drug Administration’s recent announcement that Hyland’s Teething Tablets have been voluntarily recalled because of potential toxicity is particularly disturbing. The popular organic, homeopathic teething relief contains a small amount of medicinal belladonna, an alkaloidal extract taken from the poisonous belladonna plant that can be lethal in large doses.

Hyland’s Teething Tablets should be discarded immediately, company says

According to Hyland, any teething tablets should be thrown away immediately. For safe replacements, parents are advised to contact the company at hylandsteething.com/recall or 877-496-5044. The customer service call center is open Monday through Friday, 8 a.m. to 10 p.m. Eastern Standard Time and Saturday and Sunday, 9 a.m. to 5 p.m.

Belladonna must be ‘carefully controlled’

The FDA reports that while belladonna does have a history of being used as an anesthetic, its use must be carefully controlled. This is particularly true when young children are involved. Laboratory analysis has found “inconsistent amounts of belladonna,” yet parents are advised to err on the side of caution. This is in part because the FDA has gotten reports of children suffering adverse effects consistent with belladonna toxicity (dilated pupils, blurred vision, light sensitivity, confusion, rash, constipation, etc.). Considering that Hyland’s Teething Tablets packages are not manufactured with child resistant caps, the danger is obvious.

Hylands Teething Tablets included in the recall

  • Hyland’s Teething Tablets, 125 tablets, UPC #3 54973 75041
  • Hyland’s Teething Tablets, 250 tablets, UPC #3 54973 75042
  • Hyland’s Teething Tablets, 125 tablets, UPC #3 54973 75066
  • Hyland’s Teething Tablets, 50 tablets, UPC #3 54973 75044
  • Hyland’s Teething Tablets, 145 tablets, UPC #3 54973 75121
  • Hyland’s Teething Tablets, Clip Strip 6×125 tablets, UPC #3 54973 35109

Sources

Babble.com

U.S. Food and Drug Administration

Wikipedia

What moms want to know, from a mom

Previous Article

« A few safety precautions when repairing your car

Safety should be of high importance. You can easily hurt yourself when working in tight places under the hood. Check out some of these tips. A man working on car repairs.
Next Article

Rice, Texas hit by F2 tornado that injures four »

Residents of the tiny town of Rice, Texas saw their school and homes ripped apart by a moderate tornado on Sunday night. Tornado

If you found this article helpful, share it with a friend!

  • Caring mom

    My daughter was checked as soon as she had one and am thankful I found a doctor who knows about homeopathic medicines, especially belladonna, being it is used to constrict the bladder for people with bladder issues, so that should tell you something there! And in reading a lot of the other posts they did have their children checked.
    Well I didn't MISUSE the product at all, per the doctor, she was just one of the 1 in who knows how many children who got every side effect known to man on belladonna! And I met with a doctor who knows more about plant medicines than anyone who claims to be a doctor, he got a degree for medicine and plant medicine, as well as homeopathic medicine and it was related, so I know where I can place the blame, but to fausly advertise a product is pretty rediculous in itself as well. Medicines change, plants change, the earth changes and no one person is the same, so being I have had enough of opinions from more than one dr and i have done the research on belladonna, I know what it does, it shouldn't be in there and the product should be relabeled! Just because something was fine 85 years ago doesn't mean it is now, look at tylenol and ibuprofen and ummm lets see the similac recall, would you like me to go on????????????????
    It was related and show me your degree for your proof you know.

  • zkmlr

    For the couple of moms whose babies are having seizures……please have them checked ASAP as it's very possible that it's not even related to the teething tablets. My daughter is 10 now and when she was a baby (and) teething, everyone we knew with babies used this product and no one seemed to have had a problem. My daughter is in the Gifted program, so obviously, the teething tablets did not cause any brain damage! Most often, misuse of a product is the cause of "adverse events or side effects". People are willing to believe everything they read………

    A product that has been around for 85 years can't be bad. They again, this is a nation where it's so easy to place the blame on someone else.

  • Caring mom

    You know I read most of the posts and replies and some of you make me sick! I FOLLOWED THE DIRECTIONS TO A TEE and to almost have some blame parents for hurting their children, SHAME ON YOU!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! My daughter was given the dosage recommended on the bottle, that low enough of a dosage, she still got the agitation, the constriction to the bladder (WHICH BY THE WAY IS WHAT BELLADONNA IS USED FOR, PER MY DOCTOR!), a very rare and severe type dermatitis as soon as I stopped this product, not only that, she is finally peeing normal, no more seizures, muscle weakness (she at 15.5 months is FINALLY crawling and walking and getting up on her own without shaking). The doctor I saw, not only went to school for regular medicine, but plant medicine as well, so he knew instantly what was wrong with my daughter, sad part? My daughter had an infection for 13 months and it took that long to find a doctor who took the time and INSTANTLY knew what was wrong when I told him everything I did. I DID NOT SHOVE THESE PILLS DOWN MY DAUGHTERS THROAT!!!!!!!! AND ANYONE ACCUSING A PARENT OF DOING SO, SHAME ON YOU, YOU ARE ALMOST CALLING THEM A BAD PARENT. You people who are putting negatives to peoples needing help or are concerned, have a little bit of sympathy for them and my question to some, do you even have kids? If not you have no clue how much it hurts to see a child and baby suffering and there is nothing you can do but try to figure out what is wrong. My daughters kidneys and liver may now be effected by THE LOW DOSAGE AMOUNT!!!!!!!! You know when I called the company and asked about why the heck they would put this in the gel and such and of all things RECOMMEND it??????????????? The pharmacist there said it is less concentrated (the belladonna) that is. Well you know what, so are drugs, like cocaine, but it still has the potential of side effects! I know, I am a recovering addict from being forced to do so, 7 years sober. So you know what, have some sympathy for these lives darn it!!!!!!!!!!!!!!!!!!!! Just because it was a small amount put in the tablets, babies are small too, my daughter has her 2 year molars as well and a full mouthful of teeth, but I only gave her those when she was in severe pain and followed the instructions on the bottle!
    for the one person stating that homeopathic includes bad ingredients, then the labels should be changed! It is misleading to state no side effects and 100% natural! Because no matter the amount there are still potential areas for getting side effects, as EVERY LIFE, ESPECIALLY BABIES AND CHILDREN, ARE DIFFERENT, NO ONE PERSON IS THE SAME!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
    To those who have children like me who lives are effected by this aweful tablet, we put our lives behind our children and would do anything for them, I feel for you because my fiancee and I are going through the same thing with our daughter. I am hoping nothing is permanent, but her agitation will take up to a year to subside, but she has gotten better. The seizures fully stopped a week ago and proud to say she is walking and crawling like a champ! Her CONSTANT fever is going away now that she is being treated with an internal infection from these tablets. 13 months she has had an infection, belladonna is used to treat older people who have trouble holding their bladder, it constricts and that is what happened to my daughter. The urine was held in for so long, it was so acidic and that is how she winded up with the dermatitis. She has never had diaper rash and this was something I have never seen in my life. It spread internally, but we got to it before it fully got inside, thank goodness! People, do your homework first, I put my trust in the company and I never will EVER AGAIN on any product!!!!!!!!!! My babies life is too precious and too important to this life. God bless you all and don't let the idiocy of others make you feel like you did wrong, we trusted and they failed us and can't believe they will including that awful ingredient in child products.

  • Anne

    I used them for my children with no side effects. To the mothers whose children are suffering from seizures and other problems, have you vaccinated your children? Did the seizures start after (even up to 20 or more days later)? Look up the side effects of the multiple vaccines you are giving your young children.

  • http://www.facebook.com/profile.php?id=1521450291 Lance E. Martin

    I hope we can get these back on the shelf or purchsed soon. We are on his last small fraction of a bottle and are rationing these out for real bad bouts. He does not know why we are not giving them to him when he asks now tell me that is fair. He absolutely hates any of the other medicines and things out there for relief. IF anyone out there knows who to call or places to contact that have the new released bottles or what not out please let me know. We are dealing with molars and I-9's right now and could really use the help for the little guy.

  • http://www.facebook.com/profile.php?id=1521450291 Lance E. Martin

    Look I agree that we should all not be harsh to each other. It is not going to solve or help the matters much. With that I also agree you need to know what and how much you are giving your child. Follow directions if you are worried error on the side of caution and give a little less. I give my son these tablets as well as a dose of tylenol the generic kind for right now of course. This allows him to take a nap and or sleep his normal hours during the night. He is not overly lethargic or anything else. He takes a hour and a half to 2 hour nap no more and he wakes up feeling so much better and refreshed and is a happy child and loves doing his thing.

  • momofBKJZ

    I have 4 kids but they are 20, 18, 15, and 13 so, thankfully, we are past the teething stage. Recently I had a friend give these tablets to her baby and now her little baby girl is having seizures EVERYDAY. It breaks my heart to see what my friend is going through with her baby.

    All I see on this thread is a bunch of people being rude, mean, and just selfish in their comments. Could we try a little niceness as a courtesy? No one is perfect. If you choose to use the tablets, good luck. If you choose to immunize, great. If not, great. Don't judge others because someday you will be in their shoes getting judged yourself. Be nice.

  • Jen

    Ashlee whooping cough is effecting mostly those who ARE vaccinated as well! And for those who DO vaccinate what are you worried about? Your child should be safe if the vaccines work, RIGHT???

    Autism has been a problem for well over 20 years, try telling mothers of autistic ADULTS that it's not problematic until recently.

    Vaccines are NOT required in the U.S. do your research!! There are many exemptions and it is not the LAW.

    WOW…IGNORANCE IS NOT BLISS…your post is laughable.

    • Nurseandmom

      Jen, I work in the medical field, you should do your research on whooping cough because you are significantly wrong!!! My child had been getting his recommended vaccines/immunizations and no more. I believe it is up to the mother/family wether or not they want to vaccinate! Yes Vaccines are not required to attent school but if your child wants to do certain things like sports or work in the medical field of any sort they are required to have certain vaccines! We are adults here not children so be a little less rude and snobby! since you said Ashlee's post was laughable, well so is YOURS! Be nice and don't be so naive about everything you read.

  • Ashlee

    Some of you people are idots! No wonder whooping cough is going around because you people decide NOT to vaccinate your children. Vaccines have been given for years and Autism was never a major issue until recently. And I dont know where in the US you live where vaccines are not required. You have to vaccinate to enroll in school as well as home daycare. Maybe your a stay at home parent in which case no you wont have to vaccinate your child. I dont believe vaccines are the problem , if that was the case we would all have Autism. Get with the program people.

    • Nurseandmom

      Thank you Ashlee!

      • kickstart38

        AMEN Ashlee!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
        My sister is a perfect example of that, I love her to pieces, but don't agree with her at all. My nieces get whooping cough like it is going out of style because she refuses to vaccinate and they are 5 and 7, I MYSELF got vaccinated for my baby to not give her that. If I can save just one life because of whooping cough that can kill babies, at least I can sleep at night! My daughter just got vaccinated for it as well 2 days before me. In my state some are required; however, it is up to the parent to say no if they don't want it, like my sister. I even got my baby vaccinated for the flu shot, I know some whose children almost passed because of H1-N1. I don't know about anyone else, but I want my 15.5 month old to have a long life! i love her and will protect her to no end!

  • nachole

    Wow! i was going to give my daughter some and i threw away the box also on the bottle i have 109439. but now reading all this they are going straight into the trash can! im so sorry all your kids had effects from this medication. i hope they all are better now. thank you for sharing your experience with us all.

  • JayneDeaux

    This is THE most ridiculous thing I've ever heard. My son got his 2 yr molars at nine months, now at 17 months he has all the teeth he SHOULDN'T have until 3-4!
    This is a MINUTE amount of Belladonna! How much are you idiots giving your children anyways????
    He was given LESS than the recommended dosage ( which is recommended with ANY medication especially for small children) and never ONCE had a side effect. Maybe its the myriad of other chemicals you are ramming down your child's throat without the courtesy to your child of checking them out! Actually look up what is in these supposedly "safe" vaccines! Not to mention I saw SEVERAL drs that told me its SAFE to give an infant + BENEDRYL for teething. NOTHING in benedryl is for teething, except the sleepies, which is just for lazy mothers who don't want to do their duties and take care of their children!

    • Amber

      Thank you JayneDeaux! Laziness is probably exactly the problem!! And you are correct – vaccines are NOT safe! Here in the good ol' USA we don't HAVE to give those vaccines to our kids, but most moms don't question, they just do it. I recommend researching the link between vaccines and several disorders and diseases, such as Autism! Just because you graduate or quit school, doesn't mean your homework ends when you become a mom, people!

      • cfs

        Maybe YOU should look up the doctor, Andrew Wakefield, who is currently losing his medical license in the UK for linking vaccines to autism and causing parents everywhere to panic and not get their children vaccinated. Which, in turn, has brought back relatively dormant diseases like Whooping Cough which, unlike vaccines, is ACTUALLY killing children. So before you jump on the "vaccines are evil" bandwagon maybe you should see what you're talking about. I always try the natural method first. I delivered my baby without any drugs because I was distrustful of their effect on him. But you know what there isn't a natural remedy for? POLIO, MEASLES, PERTUSSIS. So stop berating people for doing what they chose to do to keep their babies healthy—any everybody else's baby for that matter.

      • Siren

        Thanks, cfs. I'm reading this thread to gain some insight into how serious this could be. I'm amazed at the self-righteous assumptions these "good" mothers are making. How dare you attack moms trying to do what they should for their child. Lazy? I'm sorry, ladies…but unless you KNOW anyone in this thread, you may consider exercising some etiquette and class, by not judging in ignorance.

        @Jayne: Why on earth would you call a group of strangers idiots?? Is your self image THAT low? Before you embarrass yourself, at least know something of what you're speaking. The recall CLEARLY states the amounts are inconsistent. Also, consider that (just like in adults) tolerance levels differ. I understand that BellaD can be an effective treatment, but for a manufacturer to produce and distribute inconsistent dosage of an extremely poisonous plant is just stupid. If you want to call someone an idiot, direct it at them.
        and FYI – this thread isn't about benadryl and no one cares when your kid got his teeth. Again, NOT the purpose of this thread. Maybe you could take out an ad? Your post looks like the rantings of a crazy person.

        PPL – don't be lazy, do your research, follow that parent-gut that God gave you, and trust he won't lead you astray.

      • kickstart38

        Couldn't have said it better Siren!

      • Tami

        There are many vaccines that are administered to infants, the dosage of many of these are equivalent to what a grown woman receives. you remember the swine flu outbreak??? of course you do…. the entire thing was BLOWN UP. get vaccinated get vaccinated right?? did you know our own president along with the well off whom knew someone received a different vaccine from GERMANY which had long term research done on it. what were we shotting into our bodies that the more important than us couldn't take the same thing??? maybe we all need to research a little more. Vaccines are a often chosen root but more often than not just like FDA aproved drugs are harmful.

      • Nurseandmom

        totally agree!!!! Thank you:)

      • Nurseandmom

        my agreement was to cfs reply

    • tami

      doctors, the government, the FDA are all full of it. It's ridiculous who people trust about what. the side effects of a Tylenol overdose can be life threatening as bad as a coma & kindney & liver failure. i ate an entire bottle of the hylands tablets at >2 and I was COMPLETELY FINE. but yet people give FDA aproved products with dramatic side effects. sheesh

    • Nurseandmom

      certain vaccines are ok! and the dosage on any medication bottle is right otherwise it would state on it to use a lesser amount…. I don't like lazy mothers or people but if you don't get any sleep than how good of a mother could you be anyways. Pretty sure everyone is human and would get crabby or fall asleep due to complete lack sleep at anytime throughout the day! Come on now quit being rude!

    • chelsea

      I follwed the label on on Bioron's Cold Calm box, and my kid got belladonna poisong and was hospitalized for it.
      It was the most scary thing I have experienced in my life, and I do not appreciate you calling us parents who have experience this very real poisoning idiots. You should look at the box, it list alkaloid content. Though it is low, the dosing is inconsistent and not regulated, and it can poison your child. You should really not degrade other parents who have had horrific experiences with their children. That is unkind and unfair. And you really would not understand until you see a five year old hallucinating their ass off for 24 hours straight after a petite mall seizure. You are the one that should do some research and fact check yourself.

  • natural mom

    Note the recall was voluntary. People get so upset about natural remedies, but don't mind giving their children vaccines and antibiotics. Which are NOT, by the way similar to homeopathic remedies at all. Read this carefully !Belladonna can be toxic in LARGE amounts and this is virtually impossible in a homeopathic preparation. These teething tabs are so small, that even if the entire tab was pure belladonna, it would be hard to achieve toxicity without eating an extremely large quantity. Notice that the FDA didn’t say they foung toxic amounts, just inconsistent amounts. Follow the directions on the bottle. If there was any danger, the FDA would have instituted the recall instead of just threatening the company with bad press… which it is getting anyway.

    • Concerned dad

      Wikipedia says "belladonna… Ingestion of a single leaf of the plant can be fatal to an adult" I guess it depends on how you define LARGE. I wouldn't use these tablets now, knowing that there are dosage issues. I'm going to throw our bottle in the garbage.

  • jenni

    I need someone to contact me who has been to the Dr with actual side effects the doctor has told you that is what it is.. Do you have the doctors name?

    • kickstart38

      Did you ever get any info Jenni? If not let me know the Dr who caught it for my daughter knows about plant medicines as well, I know you posted this 9 weeks ago, but eh it never hurts!

  • Bridgette

    ok im very scared about this i do not have the box with the upc number but i oly have the EMPTY bottle on the bottle that i have has the number 109723 sp please let me know id any of you have this lot number

    • kickstart38

      Even if you threw out the box, you can still have the number on the bottle, the bottles of every product have to have a number on them, I had found the number on the bottle and it was in the recall

  • ingrid

    People need to look up and understand what homeopathic medicine is!!!

    The premise of homeopathic, like with immunizations, is that a tiny bit of poison is used to help the body build an immunity or cope with the symptoms of a condition…. Many many homeopathic medicines are made from POISONS!!! That is the whole point. They are in very very low dosages which is evidently what the issue is here, a problem with dosages.

    • Maggie

      To Ingrid: Actually homeopathy is nothing like immunizations. You’re correct in saying that vaccines work by introducing a small amount of a dead virus (in some cases, it’s a live virus) into the body so that the person’s immune system will create antibodies against said virus (or bacteria). Then, if the person is ever confronted with that same virus/bacteria at a later date, the body will be able to fight it off with the antibodies it has already created. Vaccines are not 100% effective because in some cases, antibodies are not created (for various reasons) or immunity wears off over time in some cases. Efficacy rates vary among different immunizations but none of them are 100%. But neither is the birth control pill. It’s still, arguably, an effective form of birth control. Now, as for homeopathy, the man who invented it was a German physician named Samuel Hahnemann. He believed that like could treat like. That is to say, if a substance (say, belladonna) caused certain symptoms in a healthy person (vomiting, blindness or nausea, for instance), then that same substance in heavily diluted form could treat a sick person exhibiting the same symptoms (vomiting, blindness, nausea, in this example). In other words, whatever symptoms a substance caused in a healthy person, Dr. H believed that same substance (highly diluted) could cure or treat those same symptoms in a sick person. Sound implausible? It is. It’s bullshit. First of all, even if Belladonna in tiny doses could treat flu-like symptoms (or teething pain), it’s so heavily diluted, that there’s no molecule of Belladonna in the final dose anyway. When a substance is diluted 1/00 to the 30th power, it does not contain one single MOLECULE of the original substance. Now, if Hyland’s manufactured pure Belladonna pills and a baby ingested a large dose (like several bottles) that could theoretically elicit some negative side effects. For those moms whose kids suffered odd symptoms, a simple urinalysis or blood test could determine the level of Belladonna in his/her system. By the way, a little trivia: the cold and flu “remedy” called Oscillococcinum found at natural food stores and pharmacies the world over is actually made out of the liver and heart of a Barbary duck and then diluted this many times: 100 to the 200th power. Crazy, right? Also, the number of ducks the company has to kill to manufacture their production of this cold and flu “remedy” for an entire year? One. One duck.

  • I. Am Pissedoff

    What moron puts poison in ANY product, let alone an INFANTS! My baby daughter had several of these symptoms after only a fraction of their recommended dosage…there was no overdose AT ALL!!! Hylands should be put out of business period. Between this and the Infant's Tylenol…who are we supposed to trust? I hope the CEO's don't lose any sleep over this or let is disrupt their round of golf.

  • Mary Ann

    My nephew started having seizures about a month ago. The doctor told them today that they are seeing several infants on this medication having seizures. Of course he told them to stop the teething medicine immediately.

    • jenni

      we have had a similiar experiance. Is there a way I could contact you to please discuss?
      Thanks
      Jenni

  • Mary Sutton

    I have been giving these tablets to my daughter, it's been recalled, the second series of UPC numbers, I really wish that these people would pay close attention to what they're doing!!! She has been experiencing some of the affects of the deadly nightshade. I really want to know why anyone would put a poison in something that you would give a baby or an infant.

    • clm

      maybe you should read the ingredients of what youre giving your child. the bottles stated very clearly that there is belladonna in them so why would you give your own child something with poison in it

      • cfs

        you know what, belladonna can be helpful in small doses why don't you back off. obviously we all love our babies more than anything and would never give them anything that would intentionally hurt them. your rudeness is insensitive, callous and completely uncalled for.

      • Elyzabeth

        Not everyone knows what Belladonna is. Thats why we TRUST companys that make stuff specifically for BABIES. Dont be rude, she wasw asking a very general question.