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Humphrey's Teething Tablet Recall. Fact or Fiction?

 

You may have heard rumors within the last year or so that Humphrey's teething tablets were recalled as a result of FDA action and wondered whether this product is safe to use to treat your baby's teething.


humphrey's teething tablet recallFor those who haven't used them before, Humphrey's teething tablets are a homeopathic remedy made up of a combination of the following active ingredients:
  1. chamomile (for relief of pain and irritability)
  2. coffee seed (a calming aid); and
  3. calcium phosphate (to support tooth development)

Also included on the list of non-medicinal ingredients is corn starch and sugar.  

There are no clinical studies regarding the effectiveness of homeopathic teething tablets and many pediatricians are reluctant to recommend them because they have not been studied or approved by the FDA. Nonetheless countless moms swear by them and say that they are the only thing that kept them sane during those terrible teething months! 

So it probably came as a shock to many moms when word started to spread that Humphrey's had been recalled by the FDA as a result of some babies experiencing seizures.  Well, we are happy to report that these rumors are completely unfounded. While teething tables HAVE been in the news over the last several years, the recall actually related to Hyland's teething tablets and it occurred back in 2010 not in 2015.

The controversy surrounding Hyland's tablets originated from concerns that Belladonna,  one of the active ingredients in Hyland's, could be the cause of infant seizures reported by parents who had given the product to their babies.  (Humphrey's has a different formulation than Hyland's and does not contain Belladonna.)

Reports of serious adverse events in children who had used Hyland's teething tablets led the FDA in 2010 to issue a notice to consumers.  In its notice, the FDA cautioned that the tablets might contain inconsistent amounts of Belladonna and advised consumers to stop using it and discard the product.

Following the FDA warning, Hyland's temporarily took its product off the market and conducted a thorough review of its manufacturing process in conjunction with the FDA to ensure consistency in its product and, in particular, the dosage of active ingredients like Belladonna.  They also added a child-resistant cap and introduced different strengths.  Hyland's reintroduced its product to the market approximately 8 months after the recall occurred and, since 2010, there has been no further recall and no further action taken by the FDA.
Humphrey's (which, as noted above, does not contain Belladonna) has never been the subject of an FDA warning or recall.
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Note:  This article is not intended as medical advice.  Consult your pediatrician before using any homeopathic remedy or medicine on your baby..

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