Standard Homeopathic Company has issued a recall for its Hyland’s Teething Tablets after the Food and Drug Administration found that they contained a small and inconsistent amount of belladonna, a substance that can cause serious harm at large doses.
The recall was issued voluntarily after the FDA received reports of serious adverse effects consistent with belladonna toxicity in children.
The teething tablets are a homeopathic product intended to provide temporary relief of teething symptoms in infants that is sold over the counter. While the tablets have always been manufactured to contain a small amount of belladonna, an FDA analysis found that the recalled products contained inconsistent amounts of the plant, which must be carefully controlled.
Belladonna, also commonly referred to as deadly nightshade, can cause seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating and agitation when ingested in high doses, according to the FDA.
Additionally, the FDA found that children were consuming more tablets than recommended, because the containers do not have child-resistant caps.
Parents are being instructed to dispose of the tablets and to contact a doctor if their child exhibits any of the above symptoms.
Standard Homeopathic Company acknowledged in its own press release that adverse effects had been reported by consumers who purchased the teething tablets, but said that the FDA has yet to find a conclusive link between the symptoms and the tablets. They blamed the recall not on the presence of the belladonna, but rather the lack of uniformity in its dosage.
“After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers,” the company said in a statement.