Botulism Alert: ByHeart-brand infant formula linked to 13 illnesses in 10 States

SEATTLE, Nov. 8, 2025 /PRNewswire/ -- The FDA and CDC, in collaboration with the Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), Washington (1).

"Botulism, especially in children, can be severe and even deadly," said Bill Marler, managing partner at Marler Clark, Inc., PS, The Food Safety Law Firm. "This is the first time that I have seen botulism in a dried powdered product. The fact that it is designed for infant consumption should be concerning to all," added Marler.

Outbreak Facts

• The IBTPP reported an increase in number of botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025.
• All 13 cases included in the outbreak reported to have consumed ByHeart-brand powdered infant formula.
• Official in several states are testing leftover infant formula for botulism. The testing is underway, yet results are currently unavailable but expected in the coming weeks.

Public Health Actions

FDA has been in contact with ByHeart and has recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal. ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by sick infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. FDA's investigation is ongoing to determine the point of contamination and if any additional products are impacted.

Recalled Items

On November 8, 2025, ByHeart 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.

What is Botulism

Botulism is a rare, life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium, Clostridium botulinum. The symptoms of botulism are caused by the ingestion of highly toxic, soluble exotoxins produced by C. botulinum while growing in foods. 

The incidence of foodborne botulism is rare, however, the mortality rate of someone affected is up to 65% when victims are not treated immediately and properly. Most of the botulism event that are reported annually in the United States are associated with home-canned foods that have not been safely processed.

Symptoms of Botulism

Symptoms of foodborne botulism usually begin anywhere between 12 to 72 hours after the ingestion of the toxin-containing food.

Symptoms include nausea, vomiting, fatigue, dizziness, double vision, drooping eyelids, slurred speech, difficulty swallowing, dryness of skin, mouth, and throat, lace of fever, muscle weakness, and paralysis.

Infants with botulism appear lethargic, feed poorly, are constipated, and have a weak cry and poor muscle tone.

Champion of Food Safety

William "Bill" Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli Outbreak which was chronicled in the book, "Poisoned" and in the recent Emmy Award winning Netflix documentary by the same name. Bill work has been profiled in the New Yorker, "A Bug in the System;" the Seattle Times, "30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;" the Washington Post, "He helped make burgers safer, Now he is fighting food poisoning again;" and several others.

Bill Marler practices at, Marler Clark, The Food Safety Law Firm, which is the nation's leading law firm representing victims of botulism outbreaks. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Bill has litigated botulism cases stemming from outbreaks traced to carrot juice, pesto, cheese and chili.

SOURCE Marler Clark, The Food Safety Law Firm