The Link - Important Infant Botulism Information
A total of 13 suspected cases of infant botulism have been identified across 10 states (AZ, CA, IL, NJ, OR, PA, RI, TX, WA) linked to the ByHeart Inc. infant formula. All infants had consumed this formula and symptoms began between mid-August through November and range in age from 16-157 days. All infants suspected of having disease have received treatment while laboratory confirmation continues for some. No deaths have been reported. The Centers for Disease Control and Prevention (CDC) is working with the US Food and Drug Administration (FDA) to investigate this outbreak and ByHeart Inc. has voluntarily recalled these lots of Whole Nutrition infant formula. Additionally, testing of formula samples is occurring in several states.1
- Lot Number 206VABP/251261P2 (Use by Date Dec. 2026)
- Lot Number 206VABP/251131P2 (Use by Date Dec. 2026)
Infant botulism generally occurs in infants <6 months of age but can occur beyond 1 year of age (range 1-14 months). Infant botulism is manifested by an acute afebrile, symmetric, descending, flaccid paralysis that can progress to respiratory distress or failure.
Clinical Manifestations of infant botulism include2:
- Constipation or inability to pass stool
- Decreased movement & loss of head control
- Cranial nerve palsies (ptosis, decreased ocular movements, loss of facial expressions, decreased gag reflex, and weak cry)
- Poor suck and swallow ability
- Progressive descending general weakness and hypotonia
While constipation is often the first manifestation, it alone does not warrant an evaluation for infant botulism. Infant botulism can progress quickly and if more than one manifestation is present on exam, then the patient should be immediately referred to Children’s Mercy Adele Hall Emergency Department for evaluation and treatment. Testing includes stool culture with enriched media and toxin identification in stool, enema effluent, or serum in collaboration with the state health department. Treatment is initiated as soon as botulism is suspected with BIG-IV (human botulinum immune globulin-intravenous) in collaboration with the California Department of Public Health, along with meticulous supportive care.
Provide reassurance to families that many infants have constipation or appear to have constipation from straining to pass a bowel movement and that this is not an indication of infant botulism without other accompanying signs and symptoms. Remind parents to throw away any remaining formula from the above lot numbers and to wash items and surfaces that have touched the recalled formula with hot soapy water or in dish water. provide anticipatory guidance regarding the signs and symptoms of infant botulism. Please call Children’s Mercy and ask to talk with Infectious Diseases if you have a question or are seeing an infant who you are concerned might have infant botulism but are unsure if their signs and symptoms are compatible.
References:
- Accessed on November 10, 2025. https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html
- American Academy of Pediatrics. Botulism and Infant Botulism. In: Kimberlin DW, Banerjee R, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics;2024:308-312.