Treatment and Prevention Program, and FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make toxin in it. Infant botulism often starts with constipation but is usually firs
Treatment and Prevention Program, and FDA are investigating a multistate outbreak of infant botulism linked to recalled infant formula. Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make toxin in it. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone.
- Cases: 13
- Hospitalizations: 13
- Deaths: 0
- States: 10
Recalled food
On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula:
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide. FDA reports that ByHeart Whole Nutrition Infant Formula makes up an estimated 1% of all infant formula sales in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.
What you should do
- Do not use recalled infant formula. Throw it away or return it to where you bought it.
- Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
- Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
What businesses should do
- Do not sell or use recalled infant formula.
- Wash and sanitize items and surfaces that may have touched recalled formula.
What clinicians should do
- Initial diagnosis of infant botulism is based on clinical symptoms.
- Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If you suspect your infant patient has botulism, immediately call 510–231–7600 for case consultation. Consultation is available 24/7.
- If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
- Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.
Symptoms
- Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
- If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
- Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.