Hyland's Teething Tablets: Questions and Answers
FDA Issues Warning Due to Risk of Belladonna Toxicity
What action is FDA taking?
On October 23, 2010, the Food and Drug Administration (FDA) warned consumers to stop using and discard Hyland's Teething Tablets. The manufacturer is recalling this product.
Why is FDA taking this action?
FDA is issuing this warning because the use of Hyland's Teething Tablets may pose a risk to children. FDA analysis and testing identified some Hyland's Teething Tablets that contained varying amounts of belladonna, a potentially toxic ingredient. FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. An ongoing FDA inspection at the manufacturer indicates substandard control of the manufacturing operation.
FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.
What product is affected by this warning?
FDA is warning consumers about all lots of Hyland's Teething Tablets. This product is widely sold in pharmacies, other retail stores, and on the Internet as an over-the-counter (OTC) homeopathic drug intended to provide temporary relief of symptoms related to teething in children.
What is belladonna?