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Infant botulism outbreak linked to infant formula, November 2025 | Botulism

Recalled foods
On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition infant formula:
- Lot: 206VABP/251261P2 (“Use before December 1, 2026”)
- Lot: 206VABP/251131P2 (“Use before December 1, 2026”)
ByHeart Whole Nutrition infant formula is available for sale online and at major retailers nationwide. The FDA reports that ByHeart Whole Nutrition infant formula represents approximately 1% of all infant formula sales in the United States and that this outbreak is not creating infant formula shortage concerns 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.
- If possible, note the lot number.
- Wash items and surfaces who may have touched the recalled formula using hot, soapy water or a dishwasher.
- Seek immediate medical attention if your infant has consumed ByHeart Whole Nutrition infant formula and has any of the following symptoms:
- Poor diet
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
- Symptoms of infant botulism can take several weeks to develop. Parents should therefore remain vigilant if they have used the recalled batches of infant formula.
What businesses should do
- Do not sell or use recalled infant formula.
- Wash and disinfect objects and surfaces this may have affected the recalled formula.
What clinicians should do
- The 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 has botulism, immediately call 510-231-7600 for case consultation. Consultations are 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 should 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 left untreated, infants with infant botulism suffer progressive flaccid paralysis that can lead to difficulty breathing and require weeks of hospitalization.
- Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.
Content source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)



