FDA notified consumers today 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.
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
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.
An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation. After consultation with the FDA today, the manufacturer of the product, Standard Homeopathic Company agreed to voluntarily recall Hyland's Teething Tablets from the market.
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.
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