Infant Formula Recall Linked to Unsanitary Conditions
A recall of the absolute worst kind
https://www.foodsafe...efore-outbreak/
I'm trying desperately to not add politics to this
I have started and deleted 2 posts on this. It's so aggravating.
Trendy website, though. :angry2:
No deaths when I read it this morning, hopefully that is still the case...
I'm trying desperately to not add politics to this
?
That is indeed very sad. But I don't know how politics could be involved. If so, which party would support such disgraceful act?
For an outsider (and please DO correct me if I'm wrong), the fact that everyone is apparently OK with the FDA having what appears to be no teeth whatsoever is the political end of things for me
They should be arms length from any other governing body, with laws that support their ability to do more than write a warning letter.
And, in 2023, the FDA warned the company, ByHeart Inc., about unsanitary conditions at its production facility.
Where is the follow up????
And that's where my endless rant would have started. In 2023, they knew there was several issues in their special-attention-to-the-quality, down-home, smart way to manufacture baby formula and did little to nothing. https://byheart.com/...ages/our-story
The FDA indeed has no teeth because they are in locked battle with the USDA as to who covers food. It's all so stupid.
Infants Nationwide Hospitalized With Botulism After Consuming ByHeart Formula | Food Safety
I understand, scampi. Your anger is absolutely justifiable.
I wonder how many manufacturers actually order WGS due to cost upon getting positive hits. This was a huge risk.
For an outsider (and please DO correct me if I'm wrong), the fact that everyone is apparently OK with the FDA having what appears to be no teeth whatsoever is the political end of things for me
They should be arms length from any other governing body, with laws that support their ability to do more than write a warning letter.
And, in 2023, the FDA warned the company, ByHeart Inc., about unsanitary conditions at its production facility.
Where is the follow up????
Actually it says in there they were warned for the first time in 22, no? Yeah, wtf.
Still, a government agency asleep at the wheel? Say it ain't so....
I wish I could be surprised....
Not sure when the Feds will actually wake up and do something about food safety/food law/oversight, etc. I'm sure we could all rant for a long time about this.
The Feds can't/won't risk making corporations mad. That's where they get their lobbying cash.
How cruel! It's heartbreaking to see infants go through this.
Yeah from what I found it looked like they were also involved in the recall that resulted in the formula shortage in 2022.
This is absolutely not their first rodeo - and when I saw "botulism" and "FDA recommends a voluntary recall" I about lost my mind.
I guess we should all be so thankful that the company complied with the recommendation, but to say it isn't infuriating would be a lie.
When marketing is more important than food safety:
https://byheart.com/pages/our-story
‘So we acquired a manufacturing facility in Reading, PA, and upgraded it to provide the very best conditions for our brand new infant formula— becoming only the 4th fully integrated, FDA-registered infant nutrition brand in the US (and the first new one in decades!).’
I remember a Farley’s factory closure way back when it sent out contaminated infant formula, they didn’t get a second bite of the cherry.
Regards,
Tony
Thoughts on this?
"ByHeart Inc. says it is also conducting its own testing on all ByHeart batches, and that the firm will share the results of its testing as they become available. Interestingly, the firm said in a statement issued November 11, "Neither [ByHeart], nor FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula." This claim runs contrary to a different statement issued on November 9, in which the firm said, "Today, we were made aware by CDPH that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism." The November 9 statement is in line with information released by FDA."
Thoughts on this?
"ByHeart Inc. says it is also conducting its own testing on all ByHeart batches, and that the firm will share the results of its testing as they become available. Interestingly, the firm said in a statement issued November 11, "Neither [ByHeart], nor FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula." This claim runs contrary to a different statement issued on November 9, in which the firm said, "Today, we were made aware by CDPH that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism." The November 9 statement is in line with information released by FDA."
Technically what they said is true. CDPH is the California Department of Public Health. They tested the sample and found the positive. So not the FDA, CDC or ByHeart. The firm is covering themselves.
I don't know enough to be able to wade in but the opened or not opened is material as to root cause.
There was a famous case in the UK where one sauce jar was contaminated with C. Bot. What was suspected to have happened was (probably not intentional) adulteration in store. Maybe just someone opening it to have a sniff then putting it back on shelf? People are strange.
Loyd Grossman 'devastated' by sauce botulism - BBC News
Not saying that's what's happened and I'd rather not speculate. And it would be fair to also assume that if there is contamination on site that it's sporadic, low level and really really uncommon meaning that you'd probably have to test 1000s to find a positive. We often forget that when we do micro testing on plant and assume a negative means the batch is negative.
Whatever the cause is, I hope the babies are ok and I am devastated at this failure happening. Too many people eat food with no idea that it could harm them and nor should that ever need to be something that crosses their minds.
Maybe just someone opening it to have a sniff then putting it back on shelf? People are strange.
Agreed GMO, I have seen someone do exactly that with a jar of curry sauce in a supermarket, after deciding they liked the smell, they put it back and picked up an unopened jar. I went over to tell then they needed to buy the jar they had opened as it could go off without anyone knowing.
In theory you can tell if the jar has been opened by a click-test but I wonder how many people do that or would still use the sauce. That Grossman korma sauce was strange, I would have expected spoilage organisms to have outgrown C.botulinum and have been evident. 47,000 jars recalled and the authorities failed to find a cause: https://www.foodmanu...ssman-botulism/
Kind regards,
Tony
20 NOV 2025 update: "FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations."
How broken our system is!
20 NOV 2025 update: "FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations."
How broken our system is!
Who's responsible for the follow up? Does no one do a recall list of items returned or disposed of by the retailers??
Who's responsible for the follow up? Does no one do a recall list of items returned or disposed of by the retailers
The horrible answer is that the consumer is responsible for not purchasing recalled product. US does a horrible job of enforcing recalls and following up on whether product was returned or even reported as destroyed by the consumer.
I am finding this interesting that EFSA is pretty much saying that a level of B. cereus toxin, cereulide, is acceptable.
It is suggestive that this is all turning into a can of worms.
Infant formula is not something I've ever worked in. It always struck me as a terrifying category. To mimic breastmilk, I'm assuming you need to remove pathogens yet it cannot be sterile to truly mimic what the body does. I've spoken to producers after they've had incidents which have led to infant deaths or illnesses and it breaks people. Most of the time though they know it was something that was done wrong.
But this recent spate of issues feels different. Like there are some fundamental category, ingredient and design issues which might be at fault.
In a former life we supplied whey protein from our process and it was about 2 years in that I found out it was for infant formula. Not to be crude but while it was hygienically collected, it was still "waste with value" to us. What are other suppliers further up in the chain doing?
It's all so thorny. I don't really want to wade into debates on breastfeeding or not but that would probably be the better option for most but we're not set up as a society for it. In the UK, few fathers take the paternity leave they could to support that and couldn't afford to as not all of it is paid. In the US, it's even crazier. A year maternity leave in the UK (not all paid at full rate mind you) is very normal, I'm sure many would dream of that in the US. But even here, the practical support structures of siblings and parents living nearby just aren't in place anymore for most people and even when they are, most adults are working well into the age they become grandparents. Child rearing is hard, breastfeeding while doing so is really hard.
So for money, society and equality reasons infant formula exists but we need to be sure it's safe both against acute and chronic illness and this all feels like a can of worms with every incident.