Sunday, October 24, 2010

Hyland's Teething Tablet Recall

As someone who has advocated the use of these tablets, I felt it necessary to post this recall notice.

If you have the affected lot of tablets, you can return them to the company for a refund. 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

From the FDA Website:

ISSUE: FDA notified consumers that Hyland’s Teething Tablets is being recalled because the tablets may pose a risk to children. The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.

FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

BACKGROUND: Hyland’s Teething Tablets is a homeopathic product, intended to provide temporary relief of teething symptoms in children. It is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.

RECOMMENDATION: FDA recommends that consumers not use this product and dispose of any in their possession. FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.


HereWeGoAJen said...

I'll have to check ours. We bought them a long time ago though and haven't used any in a really long time.

PamalaLauren said...

Are we okay if we use the teething gel?

Anonymous said...

I use the gel too -- the gel says "Belladonna 6X". I also have Humphrey's Very Cherry teething Pellets, which lists "Belladonna 3X". What do the Hyland's tablets list for Belladonna? How much is too much?


Katie said...

@PamalaLauren: The only recalled products are those listed, so it looks as if the gel is okay for now. I'll be watching their site for recall updates.
@ Michael: The problem seems to be that what the label says is not necessarily the amount of belladonna that is contained in the tablets. I think the 6x would be okay, but there were inconsistent amounts found in the lots mentioned.

justme said...

I'm your friendly neighborhood lurker who apparently has not been lurking as often as she should. I gave my 5 month old two of these the other night and am only just now seeing this! :( Thanks for posting!