Multistate Outbreak Of Infant Botulism Linked To Infant Formula

The Centers for Disease Control and Prevention (CDC) and public health officials in several states, including at the Minnesota Department of Health (MDH), are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula.

Botulism is a rare but serious illness caused by a toxin that attacks the body’s nerves. Botulism causes difficulty breathing, muscle paralysis, and even death.

As of Nov. 8, 13 infants with suspected or confirmed infant botulism have been reported from 10 states. One case was reported in Minnesota in August. No deaths have been reported. Infants ranged in age from 16 days to approximately 6 months.

Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.

On Nov. 8, 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. Additional lots may be recalled as the investigation continues. Parents should not use recalled infant formula and throw it away or return it to where it was purchased. If an infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms, parents should reach out to their health care provider immediately:

  • Poor feeding
  • Loss of head control
  • Difficulty swallowing
  • Decreased facial expression

ByHeart Whole Nutrition Infant Formula makes up less than 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.

Additional information about this outbreak can be found on the CDC’s website: Infant Botulism Outbreak Linked to Infant Formula, November 2025.

Additional information about botulism can be found on the MDH website: Botulism (Clostridium botulinum toxin).

Tags: botulism attorney, botulism lawyer
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Photo of Adriana Zimova Adriana Zimova

Adriana Zimova, JD, MPA, joined Marler Clark as a Litigation Attorney in October 2025.  Adriana earned her JD from Harvard Law School, cum laude, and her MPA in International Development from Harvard Kennedy School.

Following graduation from law school, Adriana joined Cleary…

Adriana Zimova, JD, MPA, joined Marler Clark as a Litigation Attorney in October 2025.  Adriana earned her JD from Harvard Law School, cum laude, and her MPA in International Development from Harvard Kennedy School.

Following graduation from law school, Adriana joined Cleary Gottlieb Steen & Hamilton LLP in Washington, DC, where she represented multi-national corporations in litigation and antitrust matters.  She later worked as a racial justice advocate, authoring a report for the Open Society Justice Initiative titled, Strategic Litigation Impacts: Roma School Desegregation, and co-directing a short advocacy video, Teaching Racism.  Adriana grew passionate about the intersection of food and public health during the time focused on her family.  Prior to joining Marler Clark, Adriana consulted on a potential high-impact public health litigation and co-authored a study on policies that regulate non-sugar sweeteners.

While at law school, Adriana served as a research assistant to Martha Minow, a former Dean of Harvard Law School, and was active on the International Law Journal and with the Harvard Human Rights Program.  She was also the recipient of the Dean’s Scholar Prize in three subjects.

In 2012, Adriana was named one of Forbes 30 under 30 in Law & Policy.

Adriana was born in rural Slovakia.  She now resides on Bainbridge Island, WA, with her husband and two children.

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