Hyland’s Teething Tablets Recall Education Repost

by Emily on September 9, 2012

When we made the transition over to the new site many of my older posts were lost in the conversion. I can still access my drafts, however, so I am going to be slowly bringing the most popular posts from the old site over here. If you have been reading my blog for awhile some of these may be repeats. Today, I decided to repost this one after having a conversation with a mom and nurse about the safety of these tablets:

The Issue:

On October 23, 2010 Hylands Teething Tablets were recalled. You can read the statement from the FDA here and the statement from Hyland’s here.

Ok, before I open this can of worms let me make one thing very, very clear. When it comes to recalls, especially for children, it is always best to be cautious. This post is NOT intended to convince you to keep your recalled products. This post is to balance out the attacks that may occur on this product simply because it is a homeopathic product. Hyland’s absolutely should have consistent levels of belladonna in their products and not having them is irresponsible. Hence the recall and the reason why you SHOULD check your bottle to make sure it has not been recalled. And as always you should keep ALL medications, vitamins, and supplements out of reach of your children whether they have child proof caps or not.

However, I did want to just give you a little bit of perspective on this whole situation from a mom who researches and uses alternative medications on a regular basis. First of all conventional food and medications are recalled ALL THE TIME. So just because this company has had a recall does not mean that it is not a reputable company. This is the first recall they have ever had in over 50 years. Do you think Tylenol can say the same?

About the Belladonna:

This is especially interesting to me because when my oldest was a baby and teething I called my pediatrician at the time and asked her about these. I was told that they contained a toxic plant and I should not use them. I have since switched pediatricians and have used them with our younger two on a regular basis. I have also become more educated as to what exactly that “toxic plant” belladonna really is. Conventional medicines typically use 0.2 to 5 mg of Belladonna alkaloids per tablet as an anti-spasmodic, roughly 1,000 to 25,000 times larger than the quantities used in Hyland’s Teething Tablets (they use 0.0002 mg of Belladonna alkaloid per tablet). So what that means is that in order for a child to have even a tiny reaction to the teething tablets a 10 pound baby would have to ingest about 1,000 tablets (which would be 6 bottles). So that means my 30 pound 12 month old would have to ingest 3,000 tablets or 18 bottles. 

Were Babies Hurt?

The only statement I can find for this recall in reference to any child being affected by this recall is this one: “Adverse events have been reported but the FDA has said that a conclusive link has not been determined”. That doesn’t sound very convincing to me, in my opinion, if there were serious effects that had been confirmed the FDA would be more than happy to let us all know. However, I am thankful that if there is even a slight chance that a company has made a mistake the FDA was quick to act in this case. Even with the recall, since there are no toxic levels confirmed, lets just say for arguments sake, that Hylands had accidentally doubled the amount of belladonna in some bottles, that still means that a 10 pound baby would have to swallow 3 bottles worth and my toddler would have to swallow 9 bottles worth.

 My Conclusion

While I do think it is important to err on the side of caution and listen to the recall, I do want you all to keep in mind that just because something is recalled does not mean that it is a bad product. We will continue to use these teething tablets in our house with our children. We couldn’t survive the teething months without them.

About

Emily is a mom on a mission. A mission to help other moms discover that being green doesn’t have to be hard, or expensive! She is a speaker, writer, and teacher on organic living and natural parenting.

{ 11 comments… read them below or add one }

Brook May 22, 2013 at 6:27 pm

I have a 15 and 5 year old and a 7 month old. I used Hyland’s tablets on the first two and recently bought the new gel for the third. I’ve never had any issue but have also, until today, never known about a recall. A friend recently posted the recall on FB and supposedly know a mom whose son had seizures and a brain bleed secondary to their use. She also claims the mom recently won a lawsuit against them. So, now I’m a little worried…

Reply

Emily May 23, 2013 at 1:19 pm

Hi Brook,

I have seen that image floating around Facebook as well. I can find absolutely no information confirming that is true. If you read the post above you will see that they were NOT recalled for causing brain bleeds, but for having uneven levels of Belladonna in them. Here is a link to the manufacturers page that discusses safety information on their products: http://www.hylands.com/news/teethinginfo.php. It is truly sad that any little one suffers at all but if the story is in fact true it could have been caused by any number of things, not just from the tablets. As you can see from the link above and the math I did in my post the amount of Belladonna in their tablets is minuscule. As moms we all have to gather information and make decisions that we think are best for our children based on the facts we can gather. I know that Hyland’s is a company that has been around since before our parents were even born and has a stellar reputation regarding quality, better than even traditional children’s medicine brands. I have even called and spoken to them over the phone in the past. I would encourage you to do that same with you questions.

I hope that helps!

Reply

YELIS May 23, 2013 at 11:22 am

HELLO

I HAVE AN 18 MONTH OLD, AND I JUST WANTED TO KNOW IF THIS ISSUE HAS BEEN FIXED? IS IT SAFE TO USE THEM NOW?

Reply

Emily May 23, 2013 at 1:20 pm

Hi Yelis,
Yes this issue has been resolved. Here is a link to a statement from Hyland’s:
http://www.hylands.com/news/hylands-teething-recall.php

I hope that helps!

Reply

Ashley June 10, 2013 at 8:30 pm

I use this product with my 8 month old and it works wonders. I have however, heard the story about it somehow causing seizures and brain bleeds in one case. I did research a bit and didn’t find the specific case, and continue to use them for my son. Not only have I used this certain product, I have used the cold tablets as well. I get great results from both of them, and not that I feed them to him like candy, but my son loves taking these little dissovable pills. I think they make him feel like a big boy. :) lol. Thanks for the extra research.

Reply

Jahanna June 29, 2013 at 1:31 am

Even though it is said that the makers of Hylands Teething tablets have made some changes to their product after the 2010 recall, they did attempt to get approval by the FDA and were still denied due to insufficient information on their changes documented appropriately. Please see the link below to the Warning Letter the FDA sent to them about correcting the violations. I looked in all the website and could not get a confirmation that they have actually gotten FDA approval at all. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm255074.htm

Reply

Emily July 1, 2013 at 9:13 am

Jahanna, thank you for sharing this information. I have not ever seen this info. I am going to email them right now and ask them clarify and I will let you know what they say. I have always been impressed with their company so I anticipate a response. I will keep you posted!

Reply

Emily July 12, 2013 at 11:06 am

Jahanna, I wanted to let you know I heard back from a Hyland’s pharmacist within 24 hours of my email. Here is their response:

Dear Emily,

Thank you for reaching out to us for clarification on this matter. We very much appreciated your original post and are happy to help you with this.

Yes, the warning letter sent to you by your reader was from the same inspection that resulted in our voluntarily recalling Hyland’s Teething Tablets in October 2010. In July 2011, we relaunched Hyland’s Baby Teething Tablets with several new features – a new child-resistant cap, more vibrant packaging, and a reformulation that improved effectiveness while increasing the safety margin. More information can be found at hylandsteething.com.

While we are confident of the safety of our products, before and after, we have been diligently addressing the matters in this letter. We are very proud of all that we have accomplished in ensuring we meet or exceed the standards set for us as an FDA-regulated homeopathic drug manufacturer.

Please let us know if we can be of further assistance.

Sincerely,

E. Frackiewicz, Pharm.D.
Pharmacist

Reply

Mommy November 6, 2013 at 1:50 pm

While I have found all research to show the new tablets are safe, I can’t help but still have a fear of what the belladonna can do to babies. My daughter who is 4 months & full on teething only gets a tablet as needed & on occasion 2 before bed so she can rest comfortably because we noticed she was restless & then even sometimes having leg twitches. The twitching would occur while awake & asleep, not a bunch like a seizure but say 6-8 good strong kicks, while laying still in an almost asleep state. To where a parent would look & wonder what was wrong… I see online that the teething can cause the restless sleep but haven’t found anything about the twitching, is it possible this is an effect of the belladonna ? I do not want her to suffer but wonder if I should continue to use….

Reply

Emily November 6, 2013 at 3:14 pm

I would ask your pediatrician this question. I personally don’t think it could be the belladonna, since as I shared above the content is minimal, but as I also stated I am not a doctor, so I cannot give medical advice. My ped is very supportive of the tablets, if your ped is not knowledgeable about natural remedies and that is something that you want to use in your family it may be worth considering a switch.

Reply

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