ByHeart Has Recalled All of Its Infant Formula

The CDC and FDA are investigating a multi-state outbreak of infantile botulism that may be connected to the consumption of ByHeart Whole Nutrition Infant Formula. The investigation is ongoing, and as of now, there are 31 cases of botulism infections that are possibly linked. There have been no deaths.

ByHeart has recalled all of its infant formula. If you are using ByHeart, you should stop, switch formulas, save the cans for testing, and watch your baby for symptoms. Testing showed that unopened and opened cans of ByHeart formula were affected.

Read on for more information on what you need to know. We will keep this page updated. If you have questions, please ask them in the comments.

What is infantile botulism?

Infantile botulism happens when spores of Clostridium botulinum—a bacterium found in soil and dust—get into a baby’s digestive system and start producing a toxin that blocks nerve signals to muscles. It’s rare (about 100-150 cases per year in the U.S.), and it almost exclusively affects infants under 12 months because their gut microbiome isn’t mature enough to fight off the bacteria. Infants under 6 months are the most at risk, as are infants who are immunocompromised.

The first sign is usually constipation, followed by a weak cry, trouble sucking or swallowing, and a “floppy” baby who seems to have lost muscle tone. Infantile botulism is treatable – there is medication and supportive care – but usually requires a hospital stay.

What causes infantile botulism?

This occurs when infants consume food contaminated with this bacteria or absorb it from the air or environment.

It is often very difficult to determine the source. Botulism generally develops 3 to 30 days after exposure, making it very difficult to determine what the exposure was. Honey is a known source of this bacteria, which is why you are told to avoid it with babies under 1 year, although it isn’t clear that this actually causes many cases (don’t freak out if your child has an accidental Honey Nut Cheerio).

Most cases of infantile botulism do not have a known cause. This is the first time an outbreak has been linked to infant formula.

What is happening with ByHeart’s formula?

There has been an uptick in infantile botulism cases this year, and in 31 of these cases, investigations identified that babies consumed ByHeart Whole Nutrition Infant Formula. This is a strong enough signal that the FDA suggested a voluntary recall. As of November 11th, ByHeart has recalled all of its formula.

Although the FDA has not yet released any confirmatory testing showing bacterial presence in formula, the California Department of Public Health has indicated that preliminary results show the presence of the bacteria in the formula they tested. ByHeart released a statement on November 19th confirming that Clostridium botulinum had been found in unopened cans of formula.

There are many unknowns here. Most people will not have saved their formula cans, making testing difficult. We will continue to learn more over time.

What should I do?

You should stop using ByHeart’s formula, even if it is not from the individual lots that have been specifically implicated. You should also save the cans you’ve been using for testing.

In addition, if you have used formula from lots that are known to be affected, keep a close eye on your baby for symptoms including constipation, weakness, and fussiness. If you are at all concerned, call your pediatrician (in fact, probably call them now to keep them in the loop). It’s essential to remember that the risk remains very small even if your baby consumed formula from these lots, but it is good to be aware.

The incubation period for botulism is 3 to 30 days after exposure, so after a month (or if you used the formula more than a month ago), you do not have to worry.

If you do need to switch formulas, be assured that formulas are all very similar in terms of their nutrient mix (due to regulation). Some babies are more sensitive to taste than others, but most babies do fine switching.

Be assured: ByHeart has its own manufacturing facilities, so there is no reason to think any other formulas would be affected by this recall.

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