Babies, Botulism, and Broken Trust

I spent many a pregnant evening scrolling through my socials in 2025, allowing myself to be influenced by new parents who were buying all the things for their soon-to-be born babies (consumerism, amirite?). What will I dress them in for sleep? What toys will help them learn? What gadgets are going to make my life easier? So many questions, near-infinite options! When breastfeeding didn’t go to plan, one of the biggest decisions I had to make was what formula I would feed my sweet little girl.

My daughter was born last fall. And no, this isn’t a story about how she fell ill from foodborne illness. This is a story of how (and why) I avoided the recent outbreak that you know I’ll be talking about, and how consumers really are at the mercy of food companies and their food safety standards. Trigger warning, I talk about the death and sickness of babies in this post.

2 dead babies, 4 sick from Abbott’s Cronobacter sakazakii outbreak in 2022.

48 babies sick from ByHeart’s Clostridium botulinum outbreak in 2025.

Now, the US isn’t the only country with outbreaks from infant formula, France had an outbreak of Salmonella enterica in 2017 that sickened 40 babies. And melamine was illegally added to infant formula in 2008 by various Chinese dairy suppliers to fake higher protein content, resulting in at least 6 dead babies causing ~300,000 poisonings- ~51,900 hospitalizations from kidney failure and kidney stones, by the way. This last one wasn’t microbiological, rather it was economically motivated, but I pose these questions to the companies involved regardless:

How could you? Better yet, how DARE you? You’re making formula- the sole source of nutrition for teeny, tiny, innocent babies- How could you let these things happen?

Was it worth it?

As I began working on this blog post, there has been not one, but TWO more infant formula incidents. A few weeks ago, babies started getting sick from infant formula that contains cereulide toxin (caused by Bacillus cereus). This is a global outbreak, and right now, there are 144 babies sick, and 2-3 babies’ deaths are being investigated as potentially associated with this toxin - caused by an ingredient - affecting many infant formula brands. And we have a new suspected outbreak of Clostridium botulinum, this time from a European brand. My heart breaks.

When deciding what formula to purchase, I already knew about the Cronobacter outbreak from Abbott, so that entire brand was off the table for my baby girl (it’s really hard to earn back trust once it’s absolutely demolished). And then, weeks before I needed to purchase formula, I heard new news about botulism in ByHeart. But here’s the kicker- while we all heard about this outbreak around November of 2025, this outbreak didn’t start then, that’s simply when FDA made their public warning. The earliest recognized case was in December of 2023. OF 2023!!!!! I won’t go into details on how poorly ByHeart handled the outbreak, but one thing I know for sure- I won’t be buying ByHeart- ever. I’m probably not the only parent who feels that way.

Because of the two recent US outbreaks, I decided not to by my baby’s formula from the U.S. Lucky for me, FDA continues to allow for personal importation of formula, giving moms like me a choice beyond what is offered in the US. I didn’t want to buy formula from the US until I had confidence that the food I would feed my sweet baby would be safe. Last night, Nara Organics, a European company, entered the chat. FDA has started to investigate several cases of infant botulism illnesses; the babies had consumed Nara Organics Whole Milk Organic Powdered Formula and FDA requested the company do a voluntary recall. I navigated to Nara’s website last night and the very first thing that popped up is a warning and a note that they’ve voluntarily recalled any formula that is suspect. A stark difference from what happened with ByHeart…but I digress.

In response to Abbott’s outbreak, FDA started an initiative, Operation Stork Speed. That was 4 years ago. I guess storks don’t really fly all that fast. They’re doing a nutrient review and reviewing formula guidelines that date back to literally before I was born. They are increasing contaminant testing for heavy metals and spore formers like what causes the ByHeart outbreak. Well, arguably, humans caused the outbreak, but tomato tomato.

This is all well and good. But I have mixed feelings about this initiative. The mom in me thinks, “too little too late, FDA. The damage has been done” and the food safety person in me says, “Yes, this is good, finally getting the attention it deserves.” But why do babies have to die before we start revising guidelines from the 80s? Why is food safety ignored until something goes horribly wrong? How many more must die before we really take a proactive approach? And at this point, you might be thinking, “But Laura, we have FSMA- we’ve modernized our food safety system!” ...but have we? Because that came out in 2011. It’s 2026 and we still have foodborne illness outbreaks- flour, papayas, eggs, romaine, cantaloupes, cucumbers, deli meats, infant formula, you get the idea.

Thinking about historical outbreaks that have resulted in sweeping changes: 4 children died and 700 were sickened by E. coli in 1993, resulting in USDA declaring E. coli O157:H7 an adulterant in ground beef; 9 dead, 714 sick after eating peanut butter that was KNOWINGLY released into commerce in the 2008 Salmonella outbreak, reminding us all that you can (and should) go to jail for things like this; and 33 dead (33!!!!) and 147 sick in the Listeria outbreak in cantaloupe in 2011-one of several produce-associated outbreaks in the 2000s; and there will be more. But how many more? Why, again, are we waiting for something to go so horribly wrong?

I’m on the inside in terms of food safety, because of my career, so I know things (sometimes things I wish I didn’t) but how many consumers blindly trust the food they consume is safe? And shouldn’t that be their right? I think a lot of people think, “well, if the product is on the shelves, SOMEONE made sure it was safe for us, otherwise they wouldn’t sell it.” Now, that “someone” could be one of many people- the regulator, the CEO, the QA, the supervisor, the food handler, the sanitor. But who is ultimately responsible- especially when something goes wrong?

I don’t think there’s a single person responsible. And the WHO, FDA, and FAO would agree, as I’ve seen them all use the phrase, “food safety is everyone’s responsibility.” But it really is. It’s everyone. It’s a food handler that feels empowered to speak up when they see something wrong, a supervisor who is constantly considering the safety of food being produced in their facility, the CEO of a company who encourages a strong food safety culture, the regulator who performs inspections to identify issues, and it’s consumers who follow safe food handling practices in their own homes that keep food safe.

So, ultimately, I suppose my message is this: Foodborne illness is 100% preventable. It’s not just about the regulations, the policies, the audits, the certifications, the inspections, or the guidance. It’s about people. PEOPLE CARING for others. People who understand that they are producing food that is going to be consumed by someone- a mother, a granddad, a friend, a coworker, a baby- and taking the time and the care to make sure that the food is produced with the upmost attention to food safety. Because if you won’t, who will?