After receiving a formal request from the Food and Drug Administration (FDA), Standard Homeopathic Company has agreed to initiate a nationwide recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, due to toxic levels of belladonna in the products that have resulted in serious adverse events in infants including seizures.
Los Angeles-based Standard Homeopathic Company is notifying its distributors and retailers and arranging for the return of the products. Consumers who have the teething tablets should stop using them and contact the company by calling 800-991-3376. Those who have experienced any problems that may be related to taking or using this drug should contact their physician or health care provider.
The FDA is reminding consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumer not to use these products. Earlier this year, the FDA announced that a laboratory analysis on the tablets found inconsistent amounts of belladonna in the homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.
Belladonna is a toxic, plant-based ingredient. Though widely regarded as unsafe, it is used in homeopathic products and supplements as a sedative to stop bronchial spasms in asthma and whooping cough, as a cold and hay fever remedy, and as a treatment for Parkinson’s disease, colic, motion sickness, and pain.
In October 2016, the FDA issued a safety alert that homeopathic teething tablets and gels, promoted to soothe teething babies, distributed by Hyland’s and other companies, had been linked to side effects in infants and children including seizures, breathing difficulties, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and agitation.
Any adverse events related to use of these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.