Oct. 25, 2010 -- The FDA says some infants who took Hyland Teething Tablets show signs of belladonna poisoning.
The product is being recalled. Consumers should immediately stop using and discard Hyland's Teething Tablets.
The tablets, a homeopathic remedy, are supposed to contain vanishingly small amounts of belladonna, a toxin from a poisonous plant known as deadly nightshade.
After inspecting the Hyland manufacturing facility, the FDA says the Teething Tablets contain "varying amounts of belladonna, a potentially toxic ingredient" and that Hyland's maintains "substandard control of the manufacturing operation."
The FDA has received reports of "serious adverse events in children taking this product that are consistent with belladonna toxicity."
Symptoms of belladonna poisoning are depressed level of consciousness, seizure, difficulty or slowed breathing, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and agitation.
If a child shows any of these symptoms after taking Hyland's Teething Tablets, call a health care professional immediately. Side effects from the product should be reported to the FDA at 800-332-1088 or at the fda.gov/medwatch web site.
As a homeopathic remedy, Hyland's Teething Tablets have not been approved by the FDA as a safe or effective drug. The agency notes it "is not aware of any proven clinical benefit offered by the product."
Manufacturer: 'Wide Margin of Safety'
Standard Homeopathic Company, the maker of Hyland's Teething Tablets, says it is recalling the product out of an abundance of caution.
"As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm," the company says in a news release. "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 says it is "refining its production, packaging, and testing protocols" in consultation with the FDA.
The Hyland’s Teething Tablets UPC codes included in the recall are:
- Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
- Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
- Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
- Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
- Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
- Hyland’s Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109