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  • Situational Update
  • Botulism

Infant Botulism Outbreak Linked to Infant Formula

  • 11.12.2025

The CDC is working with multiple partners including state public health departments, clinicians, laboratories, and the Food and Drug Administration (FDA) to investigate a multistate outbreak of infant botulism. At this time, there are no confirmed cases in Nevada that have been linked to this outbreak. However, there are confirmed or suspect cases in neighboring states.

As of November 11, 2025, all ByHeart Whole Nutrition infant formula products made by ByHeart Inc. have been recalled. This formula has been available at major retailers nationwide, including multiple stores in Nevada and through online vendors like Amazon. If you have any ByHeart Whole Nutrition infant formula products, do not use them.

 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.

State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. To date, for all cases caregivers reported feeding the infant ByHeart Whole Nutrition infant formula before symptoms started.

What is Infant Botulism:

Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make a toxin. 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.

What clinicians should do:

  • Initial diagnosis of infant botulism is based on clinical symptoms.
  • If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation with the Infant Botulism Treatment and Prevention Program at the California Department of Public Health (CDPH). This program is designated by the CDC and FDA as the point of contact for clinicians seeking consultation on suspected infant botulism. Consultation is available 24/7.
  • If clinical consultation supports infant botulism, the consulting physician will release BabyBIG®. 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 through your local health department:
    • Southern Nevada Health District (Clark County): (702) 759-1300
    • Northern Nevada Public Health (Washoe County): 775-328-2447
    • Carson City Health and Human Services (Carson, Lyon, and Douglas counties): 775-434-1690 (or (775) 887-2190 after hours)
    • Central Nevada (Churchill, Mineral, Eureka, and Pershing counties): 775-866-7535
    • Rural Nevada (all other counties): 775-400-0333

Further Recommendations:

  • If you do have any opened ByHeart Whole Nutrition infant formula products, record the lot number and best by date and if you can, keep it safely stored in case it needs to be tested.
  • Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism, seek immediate health care.
  • If you need formula resources, please see if you qualify for WIC at https://nevadawic.org/
  • For other resources, see  https://www.fns.usda.gov/fs/infant-formula

This is a rapidly-evolving outbreak. For the most recent outbreak and recall updates, please visit the CDC and FDA outbreak webpages.