11/09/2025
The FDA is investigating ByHeart, a “clean” formula brand, after 13 infants were hospitalized with suspected infant botulism possibly linked to their product from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington.
This isn’t their first issue, ByHeart baby formula was also voluntarily recalled in December 2022 for five batches due to potential Cronobacter sakazakii contamination, a dangerous bacteria that can cause severe infections in infants. No illnesses were reported at that time, but now, just three years later, we’re seeing another outbreak involving the same brand.
But this isn’t a one-time event, it’s a pattern. Another “premium” formula, another investigation, and another reminder that not all feeding options are equal.
🦠 What is infant botulism?
Infant botulism is a serious illness caused by bacteria that can produce toxins in the intestines. Symptoms can start as constipation, weak cry, poor feeding, and can progress to muscle weakness or breathing problems. It’s uncommon, but it reminds us that infant feeding isn’t risk-free, especially when we rely on mass-produced, powdered foods for newborns whose immune systems are still developing.
🙋🏼♀️ Why this matters
We keep hearing “fed is best.” But this investigation proves that how your baby is fed matters.
- Powdered formula is not sterile. The FDA and CDC have confirmed this for years. Even when prepared carefully, bacteria like Cronobacter sakazakii or Salmonella can survive and multiply in powdered formula.
- Recalls are not rare. From Abbott to Reckitt to ByHeart, contamination issues have been repeated headline stories from 2022–2024.
- Formula is not equal to breast milk. It’s manufactured to imitate nutrients, not the immune system. Human milk contains live antibodies, white blood cells, stem cells, enzymes, and prebiotics that actively protect against infection.
So no, “fed” isn’t the full story. Safe, biologically matched, immune-protective nutrition is the goal. And that comes from you.
🤱🏼 Why breastfeeding is optimal for infants
Your milk isn’t just food, it’s living medicine. It changes with every feed to match your baby’s age, health, and environment.
- It contains lactoferrin, lysozyme, and secretory IgA, which directly kill harmful bacteria and protect the gut.
- It also supports jaw and facial development in ways bottles can’t replicate.
- NOT breastfeeding increases the risk of ear infections, respiratory illness, GI infections, childhood cancers and disease.
Even partial breastfeeding provides measurable benefits. If you’re pumping, mixed feeding, or supplementing…. IT STILL COUNTS!
💛 For moms who use formula:
- Always check your formula’s lot code on the manufacturer’s site or the FDA recall page.
Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
- Use hot water (≥158°F/70°C) to prepare powdered formula, then cool before feeding. It won’t kill botulism BUT it will kill harmful bacteria like Cronobacter! https://iris.who.int/server/api/core/bitstreams/423f27ea-b94d-447c-aa0c-46cdbc80e5b3/content
- Wash hands, bottles, and scoops thoroughly and ideally sanitize everything once daily.
- NEVER “stretch” formula with extra water or save leftover bottles for later feeds.
Every mom deserves truth, not fear tactics or formula marketing disguised as science. We can acknowledge that formula saves lives and admit it carries risks, just like any medical-grade food product. When parents are informed, babies are protected.
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/response-broader-fda-investigation-byheart-initiates-voluntary-recall-two-batches-infant-formula
