Hyland's homeopathic baby tablets recalled in Australia over safety fears

Hyland's homeopathic teething tablets and gel on sale in Melbourne.
Hyland's homeopathic teething tablets and gel on sale in Melbourne. Photo: Supplied

Homeopathic teething tablets investigated over links to baby deaths in America are being recalled in Australia over fears about the effects of the potentially toxic plant belladonna.

Hyland's baby teething tablets and baby nighttime teething tablets should  be returned to their place of purchase, a Therapeutic Goods Administration bulletin advised on Saturday.

"While the TGA had tested samples of these products supplied in Australia and found no quality issues, Kadac is now recalling the tablets as a precautionary measure due to the potential safety risk that belladonna alkaloids can pose to children," it states.

"The effects of belladonna can be unpredictable and could cause serious health problems."

The recall, initiated by Hyland's Australian distributor Kadac, in consultation with the TGA, comes two weeks after the same product was recalled by its distributor in the United States.  

Last year, the US Food and Drug Administration raised the alarm about homeopathic teething products after an investigation revealed 400 reports of adverse events, including 10 deaths.

The US administration found inconsistent levels of belladonna alkaloids in the products and warned that belladonna presented a serious health hazard with unpredictable outcomes to children.

As concerns mounted in February, the TGA sampled two batches of the product in Australia and chose not to take any regulatory action after the testing had "not identified any quality issues".

Hyland's Baby teething gel is not affected by this recall. But all of Hyland's baby teething products, including the gel, will no longer be marketed in Australia.

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Hyland's released a statement following the US recall, saying it had made the difficult decision in response to a request from the FDA and that "all manufactured and sold teething medicines met the Company's safety limit tests and all tested product has been well within an established safety threshold".

Calls to Kadac's office went unanswered on Saturday.

If you have any Hyland's Baby teething tablets or Hyland's Baby nighttime teething tablets, return them to the place of purchase for a refund or call Kadac on 1300 762 025.