Given the potential for risk posed by teething tablets still in homes and stores, the FDA recently wrote to Hyland's parent company, Standard Homeopathic, urging it to finally issue a recall. The recall includes all products that retailers may have had in stock.
The maker of Hyland's teething tablets has issued a recall for any remaining packages at the urging of US regulators, who say the medicine has inconsistent levels of a herb that can be poisonous.
ISSUE: FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.
This is the second time in a decade that Hyland's has recalled teething tablets over belladonna concerns. The products remained on some store shelves for months, and were still available on the internet.
"FDA believes that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable", the company said in its recall notice.
"We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested", said J.P. Borneman, PhD, chairman and CEO of Standard Homeopathic Company.
Any questions should be directed to Standard Homeopathic Company by phone at 1-800-991-3376, Monday through Friday 6 a.m.to 4 p.m.
Standard Homeopathic Company is notifying its distributors and retailers by mail and is arranging for the return of all recalled products.
If you have these products, you should discard them. If consumers have experienced any problems that may be related to taking or using these products, they should contact their physician or healthcare provider.