Botulism Scare Triggers Sweeping Recall
In a move sending shockwaves through the parenting community,
ByHeart, the much-hyped next-generation baby formula startup, has issued a
voluntary recall of all its Whole Nutrition Infant Formula products following a nationwide outbreak of infant botulism. The recall, announced after a late-night call with the FDA on November 11, 2025, comes amid a broader federal investigation into at least 83 reported cases of infant botulism since August, with 13 of those infants having consumed ByHeart formula at some point.
What Is Botulism and Why the Urgency?
Botulism is a rare but potentially life-threatening illness caused by toxins produced by the bacterium
Clostridium botulinum. Symptoms in infants can include poor feeding, loss of head control, difficulty swallowing, and decreased facial expression. The CDC has confirmed that at least 15 babies have been hospitalized in connection with the outbreak, and health officials are urging parents to remain vigilant, as symptoms can take weeks to appear.
While the FDA has not established a direct link between ByHeart’s formula and the outbreak—and there is no historical precedent for infant formula causing botulism—the company says it is acting “out of an abundance of caution” to protect families. No ByHeart product has tested positive for
Clostridium botulinum spores or toxins, but the recall was expanded after two additional cases were reported.
ByHeart’s Response: Transparency and Support
ByHeart, known for its patented protein blend designed to mimic breast milk and its commitment to clean, organic ingredients, has built a reputation for transparency and safety. In a statement, co-founder and president Mia Funt emphasized,
“The safety and well-being of every infant who uses our formula is our absolute highest priority. We take any potential safety concern extremely seriously, and act quickly to protect families.”
The company is offering free replacements for any discarded cans from the affected batches and has set up a 24/7 hotline for concerned parents. ByHeart is also working with the FDA and CDC to support the ongoing investigation and has pledged to keep families informed as new information emerges.
What Parents Need to Know
-
Do not use any ByHeart powdered infant formula—dispose of it immediately if you have any at home.
- Watch for symptoms of botulism in infants, including poor feeding, muscle weakness, and difficulty swallowing.
- Contact your healthcare provider immediately if your child shows any symptoms.
- For questions or replacement requests, contact ByHeart at hello@byheart.com or call 1 (833) 429-4327.
The Bigger Picture: Formula Safety Under Scrutiny
This recall is the latest in a series of formula safety scares that have rattled parents and highlighted the challenges of ensuring infant nutrition products are free from contamination. ByHeart’s rapid response and open communication have drawn praise from some quarters, but the incident underscores the need for rigorous oversight and transparency in the baby formula industry.
As the investigation continues, parents and caregivers are left grappling with uncertainty—and the hope that lessons learned from this crisis will lead to even higher safety standards for the most vulnerable consumers.
Sources
1. In Response to a Broader FDA Investigation, ByHeart ...
2. ByHeart Whole Nutrition Infant Formula
3. UPDATE: All ByHeart Whole Nutrition Infant Formula ...
4. News Flash
5. CDC says 2 more infants hospitalized in botulism outbreak as ...
6. CBS News | Breaking news, top stories & today's latest ...
7. Nov 8, 2025 - An Update From Our Founders
8. Whole Nutrition Formula For Babies, Infants, And Newborns
9. An Update From Our Founders
10. Patient Portals to Elicit Essential Patient-Reported ...
