The Centers for Disease Control and Prevention (CDC), and public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) report investigating a multistate outbreak of infant botulism.
As of November 8, 2025, 13 infants with suspected or confirmed infant botulism have been reported from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 13 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. Infants ranged in age from 16 to 157 days.
All 13 (100%) reported feeding ByHeart Whole Nutrition infant formula.
Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but expected in the coming weeks.
FDA has been in contact with the firm and has recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal.
ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by sick infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. FDA’s investigation is ongoing to determine the point of contamination and if any additional products are impacted.
The ByHeart team wrote the following today:
Together with the FDA, CDC and other state public health agencies, we share a common goal: protecting babies and giving families the clear, actionable information they deserve. We believe that collaboration, transparency, and decisive action are essential to achieving that goal.
We’re writing to invite immediate collaboration on the next critical step of the comprehensive investigation into infant botulism and understand the potential causes of the broader 83 cases identified by the FDA.
We believe it is in the best interest of parents, caregivers, and public health for the FDA, CDC and other state public health agencies to conduct testing of unopened cans from the recalled batches at our facility. Testing unopened cans will provide reliable evidence that will help bring clarity to families who are understandably concerned, as currently, no U.S. or imported formula is required to be tested for Clostridium botulinum.
As the FDA and CDPH continue their investigations, we stand ready to partner with them at every step, providing full access to our facilities and unopened cans, without restriction. Our shared priority should be resolving uncertainty quickly, identifying the true cause of these cases, and protecting the health and well‑being of every baby.
When we learned of this unprecedented spike in 83 infant botulism cases from FDA, we recognized the need for immediate action. The FDA alerted us that in 13 cases, babies had consumed ByHeart formula so we acted as any parents would: urgently, decisively, and with the safety of every child in mind. We voluntarily recalled the relevant batches within 24 hours, and launched our own independent testing with a third‑party laboratory using food safety best practices.
As parents, and as a business deeply committed to safety and transparency, we know how many families have entrusted us to feed their babies — and we never take that responsibility lightly.
Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.