Food recalls are increasing and now impacting infants

Question

In a new article published by ABC, ByHeart, a maker of organic baby formula, has recalled all its products nationwide after an outbreak of infant botulism sickened at least 15 babies in 12 states since August. All affected infants were hospitalized but no deaths have been reported. The company first recalled two batches but later expanded it to all products, including ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches, sold in major retailers like Target, Walmart, and Whole Foods. Parents are urged to stop using and throw away any ByHeart formula immediately.

The U.S. Food and Drug Administration said that ByHeart formula appears in a disproportionate number of infant botulism cases, despite making up only about 1% of formula sales in the U.S. While no unopened cans have tested positive, California health officials confirmed contamination in an open container linked to one sick baby. ByHeart said it made the decision “to protect babies above all else” and is fully cooperating with regulators.

ByHeart produces its formula in Iowa and cans it in Oregon, where FDA inspectors are currently investigating. The company is testing every batch with independent labs and sharing results with health officials. Infant botulism is rare but serious and affects babies under 1 year old when bacteria produce toxins in their intestines.

Answer 1

1. Brief overall summary of findings I investigated the claim that ByHeart recalled all of its infant formula nationwide due to an infant botulism outbreak, and I found the details to be entirely true. In November 2025, ByHeart initially recalled two batches after the FDA and CDC linked the formula to a cluster of infant botulism cases. Three days later, the recall was expanded to include all products, including cans and Anywhere Pack pouches, sold at major retailers. The manufacturing details are also accurate: the powder is produced in Allerton, Iowa, and canned in Portland, Oregon. While the initial reports accurately stated that only an open container had tested positive and 15 babies were hospitalized, the outbreak later grew to 51 cases. I found the official FDA documentation detailing the multistate outbreak of Clostridium botulinum linked to ByHeart Whole Nutrition Infant Formula. The FDA confirms the timeline of the recall (Nov. 8 for two batches, Nov. 11 for all products) and the hospitalization of the infants.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025