Canadian parents urged to stop using ByHeart baby formula following infant botulism outbreak in the U.S.

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“When we talk about botulism, it’s usually things like fermented meat products,” says Keith Warriner, a professor at the University of Guelph’s Department of Food Science. Sources include improperly prepared home-canned foods (such as fresh vegetables, poultry and some tomatoes), nacho cheese sauce, vacuum-packed fish, carrot juice and honey, which is why experts recommend feeding honey only to healthy children older than one year. “But deriving from formula, it came from out of nowhere, in a way.”

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Warriner says another notable feature of this case is that ByHeart recalled batches of its formula in 2022 due to potential contamination with Cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company advising that investigators had found “significant violations,” including mould in a clean-water holding tank, at its Reading, Pa., manufacturing facility.

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The company said on its website that “there are no open issues from that warning letter,” and that the Pennsylvania plant wasn’t involved in the recently recalled products.

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According to the FDA, customer information provided by Amazon shows that a “limited quantity” of ByHeart formula was distributed to 21 countries, including Canada.

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“It’s very hard to know how much exposure Canadians would have, or even know about this product, because it’s sort of a niche product,” says Farber. “It doesn’t have much share of the market in terms of powdered infant formula. So I think, in general, (it’s) very, very low risk, because the exposure of the product in Canada is very, very low.”

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Most outbreaks are sporadic cases, adds Farber, and it can be complicated for health authorities to make a connection between them. “That’s why, for example, even though there were cases reportedly back a year ago, it becomes very difficult for those working in public health to actually trace these individual cases to a particular product because they may see one in the eastern part of the United States, another one in the west and another in the south, and it’s very hard to make a connection,” he says. “But we are getting better.”

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The toxin that causes botulism attacks the body’s nerves, resulting in progressive paralysis that descends from the head through the body. Symptoms in infants can include difficulty swallowing and loss of head control (“head drop”). The illness is treated with an antitoxin.

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If you have ByHeart baby formula, “Don’t use it. Basically, lock it away,” says Warriner. Clearly label the container “Do Not Use,” but don’t dispose of it. Symptoms can take time to develop, and if illness sets in, officials can test the product for botulism spores.

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Warriner draws a parallel between ByHeart and the Abbott baby formula recall of 2022, which resulted in the closure of a factory in Michigan after the FDA launched an investigation into Cronobacter infections among infants. The plant’s closure “fuelled a national shortage” of baby formula, The New York Times reported at the time.

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“Maybe this is a consequence of having so few providers of infant formula,” says Warriner. “Is it a case of these highly centralized facilities? Are they the best thing to have when we’re looking at things like infant formula, because it makes the chain so vulnerable?”

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