I have Questions: Where else did the supplier of whole milk powder implicated by the FDA in the ByHeart Botulism Outbreak send its product? Is that supplier linked to other infant botulism cases?

Today, January 23, 2026, the CDC and FDA reported that two samples collected by FDA tested positive for Clostridium botulinum type A: 

One is a ByHeart powdered infant formula closed product sample that matches a clinical isolate from an infant included in this outbreak according to whole genome sequencing analysis (WGS). 

The second whole milk powder sample was collected by FDA at a supplier to ByHeart and analyzed by the New York Wadsworth Laboratory. WGS analysis showed that the Clostridium botulinum found in the sample of whole milk powder is a genetic match to the Clostridium botulinum detected in the finished product sample of ByHeart’s infant formula, according to analysis conducted by ByHeart.

These samples also match two isolates of whole milk powder, an ingredient that ByHeart uses in the production of ByHeart Whole Nutrition powdered infant formula, which were collected and tested by ByHeart.

Interestingly on November 18, 2025 the FDA expanded its recall recommendation to include all ByHeart infant formula products due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP). 

At that time only 15 children were linked to ByHeart.  That number now stands at 51.

The FDA further reported that according to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Among them, 36 (43%) had any powdered infant formula exposure. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula. This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

Now we know that at least 51 of the 84 (assuming it is not more than 84), are linked to ByHeart.

I have Questions: 

Where else did the supplier of whole milk powder implicated by the FDA in the ByHeart Botulism Outbreak send its product?  

Is that supplier linked to other infant botulism cases?

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.