Homeopathy company launches nationwide recall of tablets blamed for infant seizures

STAT
Updated
Hyland's said it was recalling the tablets following an FDA investigation into whether they were responsible for hundreds of "adverse events."

One of the nation’s largest homeopathy companies announced Thursday that it was recalling all of its infant teething tablets at the request of US regulators, following reports that the tablets had caused seizures and other severe complications in hundreds of infants.

The company, Standard Homeopathic, said it was recalling the tablets at the request of the Food and Drug Administration, which had concluded that they contained inconsistent amounts of belladonna, an herb known colloquially as “deadly nightshade.”

In diluted form, the substance was not expected to pose any health risk. But over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in hundreds of infants who had been given the product, according to a STAT investigation. Some became delirious; others had to be rushed to the hospital after their legs and arms began twitching.

Following a warning from the FDA in September, Hyland’s, a subsidiary of Standard Homeopathic, said that it would no longer manufacture the teething products. But the company insisted that the agency had failed to show a scientific link between the teething tablets and infant seizures. The products remained on some store shelves for months, and were still available on the internet.

Under the recall announced Thursday, the company will notify distributors and retailers and arrange for the return of all the products.

In a statement, Hyland’s said it was a “very difficult decision.”

“It is important for you to know that all manufactured and sold teething medicines met the Company’s safety limit tests and all tested product has been well within an established safety threshold,” the company said in a statement. “With this recall, Hyland’s is adhering to what its regulating agency has formally requested.”

The FDA says any homeopathic teething tablets containing belladonna pose “an unnecessary risk” and urges consumers not to use them.