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Infant Formula Recall Linked to Unsanitary Conditions

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Scampi

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Posted 10 November 2025 - 08:19 PM

A recall of the absolute worst kind

 

https://www.foodsafe...efore-outbreak/

 

I'm trying desperately to not add politics to this


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Setanta

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Posted 10 November 2025 - 08:37 PM

I have started and deleted 2 posts on this.  It's so aggravating.

 

Trendy website, though.  :angry2:


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TimG

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Posted 10 November 2025 - 08:43 PM

No deaths when I read it this morning, hopefully that is still the case...


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MDaleDDF

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Posted Yesterday, 01:23 PM


I'm trying desperately to not add politics to this

?


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kconf

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Posted Yesterday, 02:47 PM

That is indeed very sad. But I don't know how politics could be involved. If so, which party would support such disgraceful act? 


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Scampi

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Posted Yesterday, 03:19 PM

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???? 

https://www.foodsafe...efore-outbreak/


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Setanta

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Posted Yesterday, 03:37 PM

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.


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kconf

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Posted Yesterday, 03:43 PM

Infants Nationwide Hospitalized With Botulism After Consuming ByHeart Formula | Food Safety

 

I understand, scampi. Your anger is absolutely justifiable. 


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kconf

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Posted Yesterday, 03:45 PM

I wonder how many manufacturers actually order WGS due to cost upon getting positive hits. This was a huge risk. 


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MDaleDDF

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Posted Yesterday, 04:26 PM

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???? 

https://www.foodsafe...efore-outbreak/

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.


Edited by MDaleDDF, Yesterday, 04:27 PM.

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Setanta

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Posted Yesterday, 05:23 PM

The Feds can't/won't risk making corporations mad. That's where they get their lobbying cash.


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kconf

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Posted Yesterday, 05:29 PM

How cruel! It's heartbreaking to see infants go through this. 


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qa_maddy

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Posted Yesterday, 09:07 PM

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. 


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Tony-C

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Posted Today, 03:45 AM

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


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Shrimper

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Posted Today, 01:08 PM

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."

 

https://www.food-saf...390E5367667G7J 


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kfromNE

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Posted Today, 01:27 PM

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."

 

https://www.food-saf...390E5367667G7J 

 

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. 


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GMO

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Posted Today, 02:08 PM

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.


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