The Food and Drug Administration (FDA) has contacted Standard Homeopathic Company regarding a recall of Hyland’s homeopathic teething tablet products.
The agency says its laboratory analysis found inconsistent amounts of belladonna, a toxic substance -- sometimes far exceeding the amount claimed on the label.
FDA says such products pose an unnecessary risk to infants and children and urges consumers not to use them.
At this time, the company has not agreed to conduct a recall.
Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
In 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.
What to do
The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession.
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.