October 25, 2010
Hyland's Teething Tablets recalled
The FDA has notified consumers of a recall of Hyland's Teething Tablets because the tablets may pose a risk to children. Hyland's Teething Tablets are manufactured to contain a small amount of belladonna. For such a product, it is important that the amount of belladonna be carefully controlled because it can cause serious harm in larger doses. FDA laboratory analysis found that Hyland's Teething Tablets contain inconsistent amounts of belladonna. Additionally, 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.
The FDA advises consumers to consult their healthcare provider 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.
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). 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230764.htm.