Standard Homeopathic issued the recall at the request of the U.S. Food and Drug Administration (FDA), which found inconsistent amounts of belladonna alkaloids in the tablets that can be different from what is listed on the packaging.
The recall affects all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets.
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” FDA stated to Standard Homeopathic.
From 2006 to 2016, FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel. Agency records show at least eight cases in which babies died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.
Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets are used to provide temporary relief of teething symptoms in children.
The company stopped producing and shipping the teething tablets in October, but they could still potentially be on some store shelves.
Consumers who purchased any Hyland’s Teething Tablets affected by this recall should discard them immediately or return them to the place of purchase for a full refund.
Source: WFTV Orlando