Standard Homeopathic Company, the Los Angeles-based maker of Hyland's homeopathic teething products, recalled all of its teething tablets and nighttime teething tablets, the announcement said. The FDA concluded that the products have mislabeled the amounts of belladonna alkaloids they contain.
Dr. Natasha Burgert, a Kansas City-based pediatrician, said that many parents of her patients have asked her about the latest recall.
"Belladonna is a natural plant that has been used for centuries," she said.
Burgert added that while belladonna can be harmful, "my suspicion is that, when using it in teething tablets at homeopathic doses, the likelihood of a significant reaction is likely low," she said. "However, I think it is appropriate for the FDA be concerned that these homeopathic tablets and regimens are not regulated."
In January, the FDA urged parents not to use Hyland's homeopathic teething products after finding that the products contain varying amounts of belladonna, a toxic substance, commonly known as deadly nightshare,that can be harmful to children.
Tendeaths and other adverse events, such as seizures and vomiting, previously were reported to the FDA and the agency investigated those reports last year.
"We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested," said J.P. Borneman, chairman and CEO of Standard Homeopathic Company, in the announcement.
"We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company. We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust," he said.
This isn't the first time that Hyland's teething tablets have been recalled. In 2010, Standard Homeopathic voluntarily recalled the tablets to address concerns with the product's manufacturing process and refine its production, packaging and testing protocols.
At the time, adverse events were reported, but the FDA said that it could not confirm a conclusive link between the events and the teething products.
Hyland's homeopathic teething tablets date back to 1945, when they were introduced to the US market and have been used by millions of children, according to the company's website.
Teething usually begins when a baby is between six and eight months old.
Signs of teething include acting irritable, biting or chewing, drooling, gum swelling and tenderness, refusing food, and sleeping problems.
See the latest news and share your comments with CNN Health on Facebook and Twitter.
"Teething is not a medical problem. Teething is natural, it's important, and the vast majority of kids really do great," said Burgert, who is also a spokesperson for the American Academy of Pediatrics.
"So, teething isn't something that parents should be worried about or something that need tremendous action plans, however, if they do notice their kids are fussy and biting on things we can address them in many ways," she said.