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Lingering Danger: FDA Warns Contaminated Baby Formula Linked to Botulism May Still Be Available

  • Nishadil
  • November 21, 2025
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  • 3 minutes read
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Lingering Danger: FDA Warns Contaminated Baby Formula Linked to Botulism May Still Be Available

There's a really worrying alert making the rounds, and it's something every parent, grandparent, or caregiver absolutely needs to know about. The U.S. Food and Drug Administration (FDA) has put out a serious warning: certain batches of ByHeart Whole Nutrition Infant Formula, which have been linked to infant botulism cases, might still be sitting on store shelves, even after a recall that happened way back in February of 2023. It’s a truly concerning situation, isn't it?

Infant botulism is no joke; it's a rare but incredibly serious illness caused by toxins from Clostridium botulinum bacteria. For little ones, the symptoms can be quite severe, ranging from constipation and a general lack of energy to weak cries and poor feeding, and even muscle weakness. Imagine seeing your baby struggle with that – it's every parent's nightmare. The FDA's recent reminder comes after they received reports indicating that despite ByHeart's voluntary recall last year, these potentially contaminated cans are still out there, possibly waiting to be purchased by unsuspecting families.

So, what exactly are we talking about here? The specific formula in question is ByHeart Whole Nutrition Infant Formula, sold in 24 oz (680g) cans. It’s crucial to check the lot numbers if you have this product at home or see it in a store. The affected lots include 22316 RH1, 22317 RH1, 22318 RH1, 22319 RH1, 22320 RH1, 22321 RH1, 22322 RH1, and 22323 RH1. These particular batches were manufactured between June 2022 and January 2023, and they were distributed nationwide, meaning they could realistically be anywhere.

The company, ByHeart, initiated its voluntary recall on February 13, 2023, after tests revealed the potential for contamination with Clostridium botulinum and Clostridium sporogenes. It’s understood that the contamination likely originated from an ingredient supplied by a third party, which, you know, can happen in complex supply chains. However, the fact that these products are still surfacing almost a year and a half later really highlights a significant challenge in ensuring public safety, doesn't it?

What makes this even more unsettling is that this isn't the first time ByHeart has faced scrutiny. Back in December 2022, the FDA actually sent the company a warning letter. That earlier letter was about concerns regarding conditions at their facility that could lead to contamination with Cronobacter sakazakii, another dangerous bacterium for infants. While distinct from the current botulism issue, these recurring warnings certainly raise questions and add a layer of concern for parents trying to make the safest choices for their babies.

The message from the FDA is crystal clear: if you have any ByHeart formula with those specific lot numbers, do not use it. It's imperative to dispose of it immediately. And if you’ve already used it and your infant shows any symptoms of botulism, please seek emergency medical care right away. For stores, the directive is equally unambiguous: remove these products from your shelves without delay. Our little ones are incredibly vulnerable, and their safety really does depend on swift, decisive action from all of us.

Disclaimer: This article was generated in part using artificial intelligence and may contain errors or omissions. The content is provided for informational purposes only and does not constitute professional advice. We makes no representations or warranties regarding its accuracy, completeness, or reliability. Readers are advised to verify the information independently before relying on