Hyland's Teething Tablets Recall Information - Mothering Forums

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#1 of 29 Old 11-03-2010, 02:20 PM - Thread Starter
 
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For the most updated information on the recall of Hyland's Teething Tablets,
please click here.

ThaoL and Mary B from Hyland's have both graciously agreed to answer any questions MDC members might have concerning this recall.

Please post any concerns you might have to this thread, and either Thao or Mary will post here to respond to your questions as soon as possible.

Thanks!

Quote:
Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process

Los Angeles, October 23, 2010 – Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.

The Hyland’s Teething Tablets UPC codes included in the recall are:

1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109

Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.

After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.

Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 10 a.m. to 4 p.m. Eastern Time).

“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.

No other Standard Homeopathic Company products are affected by this recall.

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit www.hylands.com or www.facebook.com/Hylands.Health.

About Standard Homeopathic Company

Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland’s brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté, Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family.

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#2 of 29 Old 11-03-2010, 08:15 PM
 
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Are teething tablets ever coming back or are they recalled forever?

Can you explain why only teething tablets have been recalled and not other items that also contain homeopathic belladonna?

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#3 of 29 Old 11-03-2010, 09:43 PM
 
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Based on the FAQ answers, it sounds to me that Hyland's stands behind the safety of their teething tablets. Are they safe to continue using? (And if so, where can we get more?)

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#4 of 29 Old 11-04-2010, 01:25 PM
 
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I just want to say, I've been a big fan of Hyland's products for a long time. Not sure what the backstory is here, but if my babes weren't done teething, I'd be stocking up.

There's lead in most kids' multis, and this is what the FDA is chasing down?

Hyland's, all credit to you for being extra careful, and good wishes to you in what must be a frustrating and difficult time.

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#5 of 29 Old 11-04-2010, 03:20 PM
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Thanks for hosting this forum. I'm a big fan of Hylands, especially teething tabs.

What is the deal with the belladonna link? We use belladonna all the time. Should I not be taking it or giving it to my kid?

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#6 of 29 Old 11-04-2010, 03:37 PM
 
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A few yrs back when our homeopath gave us belladonna to use for dd's reoccurring temperatures (after she suffered a small febrile seizure) my mom who is an rn totally freaked out. she said it was toxic and that our dr didnt know what he was doing. i looked it up and gave it to her, it worked like a charm and allowed me to give be a minimum of tylenol/ibupr to keep the temps down and avoid more seizures. when i first heard about the hylands recall, that is the first thing that came to my mind....my first instict is to think that this whole thing is a similar alarmist type of thing....i agree with the above poster who said she would be stocking up if she still had any teethers. jmho

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#7 of 29 Old 11-04-2010, 04:49 PM
 
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i must be totally dense cuz i cant quite understand why they got recalled, can someone help me out?

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#8 of 29 Old 11-04-2010, 05:06 PM
 
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Whoah! Ineed to stock up! When will they be back on the market?

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#9 of 29 Old 11-04-2010, 05:12 PM
 
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Thanks for the thread, subbing, and should I pick up some extras? Is there another similar kind? I usually don't "do" homeopathic, but you can't fool a teething baby!

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#10 of 29 Old 11-04-2010, 06:40 PM
 
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#11 of 29 Old 11-04-2010, 07:46 PM
 
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Everyone here seems to be pretty supportive of Hylands, but I'm kind of surprised! I used them with my older 2 and admit they seemed to work but what the recall is saying is that the amounts of active ingredients (ie: beladonna) can vary from batch to batch (or tablet to tablet??). That is REALLy concerning to me! First of all, isn't the whole point of homeopathy that small, specific doses are used at specific intervals to affect a change? And second of all, belladonna IS toxic so the dose must be carefully regulated. If hylands has been selling tablets designed for infants and the dose is not completely standardized then I am either (at best) wasting my money by giving my child something that doesn't have the correct dose to be effective or (at worst) giving my child too much of a toxic substance! I was a big believer in Hylands and have used several of their remedies in the past but I have gotten rid of all of them and will not be buying any for the foreseeable future.

I will say this press release makes it less ominous sounding that what I'd hear last week on the news and in the AP. Those recall notices made it sound like there had been instances of infants showing belladonna overdose (lethargy, etc.). I'm glad to hear that wasn't the case. Still, my trust has been completely shaken.
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#12 of 29 Old 11-04-2010, 08:30 PM
 
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I used this product with our first 2 children and will definatly be trying to get my hands on more for our 3rd due in a couple months before I can't find it anywhere. I think the bigger issue is giving children "too much" of this product. Alot of people think that if a little is good, a little more is better especially when we are talking about something that would normally be quite a low dose.
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#13 of 29 Old 11-05-2010, 01:28 AM
 
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Quote:
Originally Posted by calebsmama03 View Post
Everyone here seems to be pretty supportive of Hylands, but I'm kind of surprised! I used them with my older 2 and admit they seemed to work but what the recall is saying is that the amounts of active ingredients (ie: beladonna) can vary from batch to batch (or tablet to tablet??). That is REALLy concerning to me! First of all, isn't the whole point of homeopathy that small, specific doses are used at specific intervals to affect a change? And second of all, belladonna IS toxic so the dose must be carefully regulated. If hylands has been selling tablets designed for infants and the dose is not completely standardized then I am either (at best) wasting my money by giving my child something that doesn't have the correct dose to be effective or (at worst) giving my child too much of a toxic substance! I was a big believer in Hylands and have used several of their remedies in the past but I have gotten rid of all of them and will not be buying any for the foreseeable future.

I will say this press release makes it less ominous sounding that what I'd hear last week on the news and in the AP. Those recall notices made it sound like there had been instances of infants showing belladonna overdose (lethargy, etc.). I'm glad to hear that wasn't the case. Still, my trust has been completely shaken.
Take a look at what they have to say on their website about it. They have said that a child would need to take significantly more doses than what is recommended to even experience dry mouth.

To others, they have indicated they are working to re-launch the product, including adding a child proof cap (which I'm glad for).

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#14 of 29 Old 11-05-2010, 11:36 AM
 
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Bathrobe Goddess: Yes, Hyland's has begun working on reformulating and redesigning packaging for the relaunch of our better-than-ever Teething Tablets in early 2011. The new version of Teething Tablets will have a child-resistant cap and a concentration of homeopathic Belladonna that has an even higher safety margin than the original formula. We're open to hearing your suggestions for other improvements!

With regard to your question about other Hyland's products containing Belladonna: Our other products provide an even larger margin of safety as they contain a lower concentration of homeopathic Belladonna, a higher potency (6X or more). Complementing this scientific fact, we have no knowledge of any Adverse Events reported around other products containing homeopathic Belladonna, and none of them are marketed for use by infants. Our distribution of other products containing homeopathic Belladonna is much more limited than that of Teething Tablets.

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#15 of 29 Old 11-05-2010, 12:43 PM
 
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Quote:
Originally Posted by Flower of Bliss View Post
Based on the FAQ answers, it sounds to me that Hyland's stands behind the safety of their teething tablets. Are they safe to continue using? (And if so, where can we get more?)
Flower of Bliss: While Hyland's believes that our Teething Tablets are safe, the FDA has advised consumers to discontinue their use. Hyland's Teething Tablets will be off the market until we resolve manufacturing process issues and reformulate the product to have an even larger margin of safety, sometime in early 2011. We'll keep you posted on the re-launch!

Thao Le
Marketing Director, Hyland's, Inc.

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#16 of 29 Old 11-05-2010, 12:51 PM
 
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Quote:
Originally Posted by mamafish9 View Post
I just want to say, I've been a big fan of Hyland's products for a long time. Not sure what the backstory is here, but if my babes weren't done teething, I'd be stocking up.

There's lead in most kids' multis, and this is what the FDA is chasing down?

Hyland's, all credit to you for being extra careful, and good wishes to you in what must be a frustrating and difficult time.
The outpouring of support from moms like you has buoyed us immensely during this crisis. Thank you for standing by us.

The safety of our consumers - especially the littlest ones - is our paramount concern, and Hyland's wants to do what's right. In this case, we believe that it's appropriate to take the product off the market until we resolve any substantive concerns. We regret this inconvenience to you, since we know firsthand how trying teething can be for infants and their families.

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#17 of 29 Old 11-05-2010, 12:55 PM
 
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I posted about this a few months ago...friend of mine on facebook is pretty convinced her baby and several others contracted botulism from these...not sure whats the truth but Ive heard her case spurred this recall...that being said I love hylands and will miss these!

Amy, mommy to Ava, 6, Gavin, 4, Lila, 2, and Baby #4 due in early November! joy.gif
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#18 of 29 Old 11-05-2010, 01:47 PM
 
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Quote:
Originally Posted by rcr View Post
Thanks for hosting this forum. I'm a big fan of Hylands, especially teething tabs.

What is the deal with the belladonna link? We use belladonna all the time. Should I not be taking it or giving it to my kid?
Homeopathic Belladonna is generally safe to use (as directed) because the levels of alkaloids is extremely low compared to levels that are considered toxic. This is due to the serial dilution process in which the homeopathic product is prepared.

For example, a person taking conventional medicines delivering more than 0.2 mg of Belladonna alkaloids will show side effects such as dry mouth, blurred vision and urinary retention.

By contrast, one Teething Tablet (which weighs about 65 mg) is composed of 0.0003% Belladonna alkaloids as stated on the label. This means that each complete teething tablet contains only approximately 0.0002 mg of Belladonna alkaloids. The earliest non-serious side effects of Belladonna would require ingestion of more than 0.2 mg of Belladonna alkaloids or 1,025 Teething Tablets.

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#19 of 29 Old 11-05-2010, 01:48 PM
 
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Quote:
Originally Posted by amyhulen View Post
I used this product with our first 2 children and will definatly be trying to get my hands on more for our 3rd due in a couple months before I can't find it anywhere. I think the bigger issue is giving children "too much" of this product. Alot of people think that if a little is good, a little more is better especially when we are talking about something that would normally be quite a low dose.
Agreed. One should always read and follow all label directions when taking any medication.

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#20 of 29 Old 11-05-2010, 02:21 PM
 
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Quote:
Originally Posted by Amila View Post
I posted about this a few months ago...friend of mine on facebook is pretty convinced her baby and several others contracted botulism from these...not sure whats the truth but Ive heard her case spurred this recall...that being said I love hylands and will miss these!
Is there a report on this? I would love to read it.

from what I understand, you can get botulism from the environment too, so they would have had to test her tablets to know this was the source. I am very interested in reading a report on this.

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#21 of 29 Old 11-05-2010, 02:31 PM
 
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I have always be a huge Hyland's fan, and will continue to be. I look forward to using your new and improved formula for the next teething babe.

Thank you so much for this Q and A. It is nice to see that you care so much about your consumers.

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#22 of 29 Old 11-05-2010, 04:00 PM
 
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Quote:
Originally Posted by kriket View Post
Is there a report on this? I would love to read it.

from what I understand, you can get botulism from the environment too, so they would have had to test her tablets to know this was the source. I am very interested in reading a report on this.
Amila and Kriket,
This speculation was brought to our attention. Following our protocol, we immediately sent out to an independent lab to test the retained finished goods products as well as the raw materials used for Hyland's Teething Tablets. All tests of Hyland’s Teething Tablets and raw ingredients came back negative for Chlostridium botulinum, the organism responsible for botulism.

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#23 of 29 Old 11-05-2010, 04:02 PM
 
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Originally Posted by CherryBombMama View Post
i must be totally dense cuz i cant quite understand why they got recalled, can someone help me out?
The FDA has received adverse event reports they feel could possibly be related to Hyland's Teething Tablets. The evidence is non-conclusive. Because Hyland's cares about moms and babies more than anything else, being extra cautious, we are voluntarily recalling Hyland's Teething Tablets while we continue to investigate, refine and improve our manufacturing and testing process to continue to ensure safety for our consumer.

More information is available at www.hylandsteething.com/recall

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#24 of 29 Old 11-05-2010, 04:04 PM
 
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Whats the difference between the tablets and the gel? DS is teething really badly right now so I tried to find the tablets, but I couldn't find them, and ended up getting the gel. DS hates it though I have to trick him into taking it. Does the gel have to be applied to the gums or should it work the same if its swallowed in something?

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Quote:
Originally Posted by Amatullah0 View Post

Whats the difference between the tablets and the gel? DS is teething really badly right now so I tried to find the tablets, but I couldn't find them, and ended up getting the gel. DS hates it though I have to trick him into taking it. Does the gel have to be applied to the gums or should it work the same if its swallowed in something?

 

Hyland's Teething Gel has the same active ingredients as the Teething Tablets, in a topical dosage form.  The gel should be applied directly to the baby's gums but it should work the same if ingested. 

 

A second difference between the gel and the tablets is that the active ingredients in the gel are of higher homeopathic potency: this increases the strength and safety margin of the medicine.


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#26 of 29 Old 12-22-2010, 06:33 PM
 
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I had chosen the Tablets over the gel when my son started teething a year ago.

I was concerned because the gel listed parabens in the ingredients.

 

He is pushing molars now, and we are about to run out of tabletsyikes2.gif

my husband tried to get us more but we were too late.


:
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#27 of 29 Old 12-22-2010, 09:53 PM
 
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Quote:
Originally Posted by littlegreenlady View Post

I had chosen the Tablets over the gel when my son started teething a year ago.

I was concerned because the gel listed parabens in the ingredients.

 

He is pushing molars now, and we are about to run out of tabletsyikes2.gif

my husband tried to get us more but we were too late.


If it's the belladonna that's helping him, you can buy just that.  Though I wouldn't know how to doseage it for a little one. I know Boiron sells some.
 


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#28 of 29 Old 02-14-2011, 08:09 PM
 
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Is there a set date yet that the reformulated tablets will be available?  Will the ingredients be different from the recalled tablets, or will the dosage be different?

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#29 of 29 Old 02-14-2011, 09:29 PM
 
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Do you still make the Teething Pellets?  If so, why aren't they being recalled if they contain the same ingredient(s)?


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