Standard Homeopathic Company is recalling all of its Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets nationwide. The U.S. Food & Drug Administration has concluded that the medicines have been found to contain inconsistent amounts of an herb that may differ from the calculated amount on the products’ labels and could potentially be dangerous.
That herb is belladonna which has been used as a homeopathic medicine for many years but its scientific evidence of recommended use is insufficient. Because the effects of belladonna are unpredictable, the FDA believes that belladonna represents a serious health hazard to children. The FDA stated that “there is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”
The FDA began investigating the products after receiving a September 2016 comprehensive report of a child having a seizure after using one. An FDA preliminary investigation found reports of adverse effects, including 10 possible deaths, seizures, shortness of breath and tremor. Standard Homeopathic Company stopped making and shipping the medicines nationwide in October 2016.