ByHeart baby formula was recalled nationwide after 15 infants were hospitalized with botulism, exposing dangerous regulatory gaps that put America’s most vulnerable at risk.
Story Snapshot
- ByHeart expanded recall to all products nationwide after the FDA found additional infant botulism cases.
- 15 babies across 12 states have been hospitalized since August 2025, all after consuming ByHeart formula.
- The company represents only 1% of the formula market but accounts for over one-third of sick infants.
- No contamination found in unopened products, raising questions about regulatory oversight.
Nationwide Recall Expands After Additional Cases Surface
ByHeart cofounders Mia Funt and Ron Belldegrun announced the expanded recall on Tuesday, November 11, 2025, after the FDA informed them of two additional infant botulism cases.
The company initially recalled only two lots on Saturday, November 8, but broadened the action to include all ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches. Parents must immediately discontinue use and dispose of all ByHeart products in their homes, according to Chief Medical Officer Dr. Devon Kuehn.
Organic Baby Formula Producer ByHeart Recalls All Products In U.S. As Infant Botulism Outbreak Spreadshttps://t.co/FqywsusxrL pic.twitter.com/AH32Hb99Oo
— Forbes (@Forbes) November 11, 2025
Disproportionate Impact Raises Regulatory Concerns
The FDA’s investigation reveals alarming statistics that should concern every parent of 84 infant botulism cases detected since August, 36 consumed infant formula, with more than one-third receiving ByHeart products.
This represents a massive overrepresentation considering ByHeart accounts for only 1% of all infant formula sales nationwide. The company distributes approximately 200,000 cans monthly through major retailers including Target, Walmart, Albertsons, and Whole Foods.
Manufacturing Process Under Federal Scrutiny
ByHeart operates a two-stage production system that may complicate contamination tracking. The company produces formula powder at its Allerton, Iowa plant before shipping to Portland, Oregon for canning and distribution. FDA inspectors arrived at the Portland facility Monday as part of the ongoing investigation.
California health officials confirmed that an open can of ByHeart formula fed to a sick infant contained Clostridium botulinum bacteria, though no unopened products have tested positive.
Infant Botulism Threat Demands Immediate Medical Attention
Infant botulism strikes babies under age one whose immature gut microbiomes cannot fight the bacterial spores that produce deadly toxins. Symptoms include constipation, poor feeding, drooping eyelids, weak muscle tone, and breathing difficulties.
Parents must seek immediate medical care if these symptoms appear, as the sole treatment is BabyBIG, an IV medication derived from blood plasma of botulism-immunized donors. The contamination source remains unknown despite extensive testing.
