The Standard Homeopathic Company has agreed to recall Hyland’s teething tablets, after federal regulators confirmed that the medications contained inconsistent amounts of belladonna. According to the U.S. Food & Drug Administration (FDA), this potentially toxic ingredient poses a “serious health hazard to children.”
Belladonna is used in many homeopathic remedies because of its sedative effects. But ingesting excessive amounts can lead to seizures and other potentially deadly adverse events.
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” the FDA said in a statement issued on April 13th.
The Hyland’s teething tablet recall includes:
Parents and caregivers should not administer these products to children. Consumers who have recalled teething tablets in their possession should contact Standard Homeopathic at 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time). Seek medical attention for your child if they exhibit signs of belladonna poisoning, including:
Standard Homeopathic stopped selling Hyland’s teething tablets in the U.S. last October, after the FDA warned consumers not to use homeopathic remedies to treat teething pain in infants and children. At the time, the agency disclosed that homeopathic teething tablets and gels had been implicated in at least 10 infant deaths and hundreds of adverse events, many of which suggested belladonna poisoning.
The FDA’s warning prompted a number of retailers to remove homeopathic teething medications from their store shelves. In November, Raritan Pharmaceuticals announced a recall for homeopathic teething and ear pain remedies, after its products were found to contain inconsistent levels of belladonna.
The FDA confirmed inconsistent amounts of belladonna in Hyland’s teething tablets in January and issued a warning specifically for those products. The agency presented Standard Homeopathic with a formal recall request on April 10th.
Bernstein Liebhard LLP is investigating teething tablet lawsuits involving seizures, deaths and other adverse events linked to homeopathic products. To learn more, please call (888) 870-9331.