The UPC numbers involved in the recall are: 3 54973 75041, 3 54973 75042, 3 54973 75066, 3 54973 75044, 3 54973 75121, 3 54973 35109. If you’ve purchased these products and your child is experiencing side effects such as seizures, lethargy, difficulty breathing, muscle weakness, constipation, skin flushing, difficulty urinating or agitation, the FDA urges you to complete this form www.fda.gov/MedWatch/report.htm or call 1-800-332-1088.
Consumers concerned about how to return or dispose the product should go to www.hylandsteething.com/recall or call 1-877-496-5044.
ISSUE: FDA notified consumers that Hyland’s Teething Tablets is being recalled because the tablets may pose a risk to children. The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna.
FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.
BACKGROUND: Hyland’s Teething Tablets is a homeopathic product, intended to provide temporary relief of teething symptoms in children. It is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.
RECOMMENDATION: FDA recommends that consumers not use this product and dispose of any in their possession. FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.
Belladonna can be highly toxic at doses as high as a few berries. Wise people don't grow it in their gardens where children might see the pretty berries. To quote Dr Taylor, "We don't need do dilute our remedies, but we do need to dilute our toxic remedies." Homeopathy gained a foothold in the public consciousness 200 years ago when some physicians started giving much smaller doses of accepted toxic medicines. Patients got better. Before that patients had been suffering from and sometimes dying of the medicines they were given. The recovery of the patients was assumed to be due to the miniscule dose of medicine, but perhaps the cessation of toxic medication let them heal.
The hazard inherent in the modern use of homeopathy is that we keep these highly toxic substances around under the assumption that they will be diluted enough to be harmless. Here is one example of that failing to happen. Another example in recent memory is when Zicam was proved to have material doses of zinc in it, enough to cause anosmia. If Zicam had been a truly homeopathic medicine with its active components diluted as much as was claimed, it would have been inactive in terms of actually helping with a cold (which it does), and it also would not cause anosmia.
Many commercial homeopathic formulations contain material doses of some substances and homeopathic (dilute) doses of others. Homeopathy has become a loophole by which herbal medicines can get past FDA screening because the "active" ingredients are assumed to be so dilute as to be harmless. It is foolhardy of us to believe this, and I am excited to learn that FDA labs actually tested the Hyland products. Homeopathic remedies have the potential to be anything but harmless, but because we are told it is harmless, it is commonplace for people to take large and repeated doses of remedies. Protesters in Britain have been gulping down entire bottles of remedies to prove that they do nothing. I myself have eaten a half a bottle of lactose-based homeopathic tablets when that was the only "candy" I could find in the house. I can easily imagine a child doing the same thing.