Standard Homeopathic Company is recalling all remaining Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets after they were found to have inconsistent amounts of belladonna alkaloids than stated on the labels, the U.S. Food and Drug Administration (FDA) announced last week.
The FDA warned that the teething tablets from Hyland’s posed a serious health hazard to children due to the effects of belladonna being unpredictable.
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” the FDA told Standard Homeopathic Company in the April 13 announcement.
Belladonna is a common ingredient in homeopathic remedies but can pose a risk to children if given in large doses. In tests of the products, the FDA found the amount of belladonna extract in the tablets did not always match those indicated on the labels of the products.
Standard Homeopathic Company agreed to the FDA’s recall request.
“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” chairman and CEO of Standard Homeopathic Company J.P. Borneman said in the release. “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.”
Distributors and retailers of the products are being contacted by mail with arrangements made for returning the recalled products. Consumers are urged to discard the products.
Homeopathic Teething Tablets Linked to 10 Deaths
The troubles related to this batch of teething tablets began last fall after the FDA confirmed that it was investigating 10 deaths potentially connected with infant homeopathic teething products. Since 2010, the agency has received more than 400 reports of adverse effects, including seizures. This led the agency to issue a stern warning to parents that homeopathic teething solutions posed a danger to kids.
Standard Homeopathic Company discontinued the manufacture and sale of the tablets in October 2016 after the warning from the FDA but did not formally issue a recall of the products.
In January, the FDA announced its laboratories found inconsistent amounts of belladonna in Hyland’s teething tablets and contacted the company about issuing a recall. Standard Homeopathic Company declined at the time.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said at the time. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
Hyland’s Continued to Stand By Products
Up until the recall was issued last week, the company stood by the safety of its products.
“Neither we nor FDA have recalled the homeopathic teething tablets or gels,” Hyland’s said on its website in October. “While we are confident that Hyland’s Baby Teething Tablets and Teething Gel remain safe for use, it is up to you to make the decision about the medicines you administer to your child to relieve symptoms of teething.”
The company even downplayed any connection between seizures and its products until the day of the announcement.
“Hyland’s Baby Teething Tablets have safely treated the pain associated with teething for more than 85 years. There is NO scientific link between homeopathically-prepared belladonna, or Hyland’s Baby Teething Tablets, and seizures,” the website stated on the day of the recall.
That section was later removed but the company has maintained the products are safe.
Teething Tablet Lawsuits Already Pending
After Hyland’s teething tablets and others were pulled from the shelf, a class-action lawsuit was filed against the companies over allegations that they marketed useless and unsafe teething remedies.
The lawsuit, which was filed on behalf of those affected by the September 2016 warning from the FDA, claims that consumers were never issued refunds for their purchases.
More lawsuits related to the controversial teething tablets are likely to be filed in the future.