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Dec 01, 2025By Tanvi Munjal
If you've been feeding your baby formula lately, you need to know about something serious happening right now in the United States. There's an outbreak of infant botulism connected to contaminated baby formula, and 37 infants have been hospitalized across 17 states as of late November 2025.
This isn't about creating panic. This is about keeping your baby safe with the facts you need to act quickly.
What's Actually Happening
On November 11, 2025, a complete recall was issued for all ByHeart Whole Nutrition infant formula products, including every single can and single-serve packet, regardless of lot number. Preliminary testing has detected Clostridium botulinum in some samples: state investigators found it in an opened can, and the company reported positive results from third-party testing of some unopened cans; additional confirmatory testing by federal and state labs is ongoing.
Illnesses started appearing as early as August 9, 2025, and continued through November 19. That means some babies were getting sick for months before the recall happened. The cases have been reported across the United States.
What really caught investigators' attention was this: among babies who developed botulism and were formula-fed, a disproportionately high number had consumed this particular brand.
What Infant Botulism Actually Looks Like
Infant botulism doesn't show up overnight. Symptoms can take several weeks to develop, which is why parents need to stay alert even if their baby seems fine initially.
Watch for these warning signs:
- Constipation (often the first symptom)
- Difficulty feeding or sucking
- Weak cry that sounds different than usual
- Loss of head control or "floppy" appearance
- Decreased facial expressions
- Trouble swallowing
- Unusual tiredness or weakness
If your baby shows any of these symptoms and has consumed this formula, get medical care immediately. Don't wait. Infant botulism can progress to breathing difficulties and requires hospitalization. The good news is that all 37 affected infants received treatment with BabyBIG®, and thankfully, no deaths have been reported.
What You Need to Do Right Now
If you have the ByHeart formula:
- Stop using it immediately. Don't finish the can. Don't think "just one more bottle."
- Take a photo of the lot number and expiration date on the can or packet
- Label the product "DO NOT USE" and store it somewhere safe for at least a month in case health officials need to test it
- Wash everything that touched the formula with hot, soapy water or run it through the dishwasher
If your baby has been drinking this formula: Monitor them closely for the next several weeks. Keep a written log of any symptoms, even minor ones. If anything seems off, call your pediatrician right away.
Switching Formula: What Actually Works
The last thing you need right now is your baby rejecting a new formula or having tummy troubles during a switch. Here's what pediatricians actually recommend:
- Making the transition easier: Most babies do fine switching between formulas of the same type. If your baby was on a standard cow's milk formula, you can generally switch to another cow's milk formula without major issues.
- What to watch for: Your baby might be slightly fussier for a few days during any formula switch, as that's normal. But if you see vomiting, blood in stool, severe gas pain, or weight loss, call your pediatrician. That might indicate an allergy or intolerance that needs addressing.
- Special circumstances: If your baby was on a specialized formula (hypoallergenic, extensively hydrolyzed, or any prescription formula), do NOT just grab whatever's on the shelf. Call your pediatrician first. They can recommend specific alternatives that will work for your baby's needs.
The Questions Parents Are Asking
- "Can I trust other formulas right now?" Yes. This is an isolated incident with one brand in the United States. The FDA and CDC have not found issues with other formulas. All infant formula sold in the U.S. must meet strict safety and nutritional standards.
- "Should I switch to homemade formula?" Absolutely not. Both the FDA and the American Academy of Pediatrics strongly advise against homemade formula. It can be dangerous, lacking essential nutrients, or having unsafe bacterial levels.
- "How did this even happen?" The FDA is still investigating how the contamination occurred at the manufacturing facilities. The investigation is ongoing to prevent this from happening again.
Conclusion
This situation is scary, especially if you've been using this formula. But the recall is in place, treatment is available and effective, and you now know what to watch for.
Trust your instincts. If something feels off with your baby, seek medical attention.
Check the FDA's website regularly for updates on this outbreak investigation. They're updating information as testing results come in and as they learn more about the source of contamination.
Your baby's pediatrician is your best resource right now. Don't hesitate to call with questions, even if they seem small.
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