According to an April 13, 2017 press release by the United States Food and Drug Administration (FDA), Standard Homeopathic Company announced an expanded recall of all lots of its Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets sold in retail stores out of concerns for possible infant health risks from the teething aids, including death.
These tablets were designed to dissolve under a baby’s tongue in order to numb the discomfort felt during teething. The FDA has concluded that the teething medicines may contain “inconsistent” amounts of the highly toxic plant belladonna (nicknamed “deadly nightshade”), which the agency claims may represent a serious health hazard to children.
PREVIOUS TEETHING AIDS RECALL
Standard Homeopathic Company had previously stopped making and shipping the teething tablets nationwide in October 2016, following consumer complaints and reports that the FDA was investigating ten infant deaths that may have been related to the use of these products. The recall has been expanded to include all products that retailers may have still had in stock.
The company is notifying all of its distributors and retailers by mail and arranging to have the impacted products returned. Consumers are urged to discard these products immediately. They should also contact their physicians or healthcare providers if they believe their children are experiencing problems related to ingestion of the medications, common symptoms of which include seizures, difficulty breathing, excessive sleepiness, lethargy, muscle weakness, skin flushing, constipation, difficulty urinating, and agitation after use.
Consumers with further questions regarding this expanded recall may contact Standard Homeopathic Company by calling (800) 991-3376.
Those who have experienced adverse reactions following the use of these products may also report them to the FDA’s MedWatch Adverse Event Reporting program. Please call the agency at (800) 332-1088 to request a reporting form, which may be returned by mail or submitted by fax to (800) FDA-0178.
PRODUCT LIABILITY LITIGATION
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