Teething pill with belladona recalled

Hyland's Teething Tablets have been recalled

On October 23 2010 the 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.

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.

What is the danger?

FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.

The 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.

What do I do?

The FDA recommends that consumers not use this product and dispose of any in their possession.

The FDA also 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
  • agitation after using Hyland’s Teething Tablets.

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