Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets after the Food and Drug Administration (FDA) issued the company a formal recall request. The recall includes all products that retailers may have in stock; the company stopped shipping product back in October 2016.
The recall comes on the heels of an FDA investigation which found the teething tablets contained inconsistent amounts of belladonna alkaloids, which may pose an unnecessary risk to infants and children. Laboratory analysis showed that the amount of belladonna in the tablets sometimes exceeded the amount claimed on the product labeling.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. ”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.”
On January 25th, 2017, the FDA contacted Standard Homeopathic Company informing the company of these findings and ordering them to recall the products.
In a press release from the company, J.P. Borneman, PhD, chairman and CEO of Standard Homeopathic Company, said, “We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested.”
Consumers who have experienced adverse effects (ie, seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, agitation) from the use of these products should report these events to the FDA MedWatch Adverse Event Reporting program.
For more information call (800) 991-3376 or visit FDA.gov.