Standard Homeopathic Company has agreed to voluntarily recall Hyland's Teething Tablets following the US Food and Drug Administration's (FDA) warning that the tablets may pose a risk to children.
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) in retail outlets.
The FDA's warning is based on the reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.
Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses.
FDA laboratory analysis has found that Hyland's Teething Tablets contain inconsistent amounts of belladonna.
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 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.