A major infant botulism outbreak connected to ByHeart organic baby formula has grown significantly, with federal health officials now reporting at least 51 confirmed or suspected cases in 19 states since the company began production in 2022.
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have expanded the investigation to include every batch of ByHeart formula ever sold in the United States, stating they “cannot rule out” widespread contamination across all production runs.
Current Outbreak Status (as of December 2025)
- At least 51 infants affected
- Cases reported in 19 states
- States with confirmed cases: Arizona, California (highest with 9+ cases), Texas (7–8 cases), Indiana, Illinois, Kentucky, Maine, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Virginia, Washington, and Wisconsin
- Most recent known illness: December 1, 2025
- No deaths reported
Full Recall of All ByHeart Formula
ByHeart issued a complete recall of every can and batch of its infant formula sold in the U.S. in November 2025. The company has advised parents to immediately stop using any ByHeart product, even unopened cans purchased years ago.
Independent lab testing found Clostridium botulinum spores — the bacteria that cause infant botulism — in multiple lots. Officials say the contamination appears to have persisted across different production facilities, raw materials, and time periods, making it impossible to limit the risk to specific batches.
What Parents Need to Know About Infant Botulism
Infant botulism is a rare but serious illness that typically affects babies under 12 months old. The bacteria produce a powerful toxin in the child’s intestines, leading to muscle weakness and potentially life-threatening paralysis.
Common early symptoms include:
- Constipation (often the first sign)
- Weak cry
- Poor feeding or difficulty sucking
- Drooping eyelids (ptosis)
- Loss of head control
- “Floppy” appearance
- Trouble swallowing or breathing in severe cases
Symptoms can appear gradually and may take up to 30 days after exposure to develop.
The only approved treatment is BabyBIG (Botulism Immune Globulin Intravenous), an urgent IV medication that must be administered in a hospital. Early treatment dramatically improves outcomes.
History of Safety Concerns at ByHeart
This is not the company’s first contamination issue:
- 2022: Recalled five batches due to possible Cronobacter sakazakii contamination
- 2023: FDA warning letter citing ongoing manufacturing problems
- 2023: Pennsylvania facility shut down after inspectors found mold, water leaks, and insects
What Parents Should Do Right Now
- Stop using any ByHeart formula immediately — including older cans still in your pantry
- Check with your pediatrician if your baby has ever consumed ByHeart formula and is showing any symptoms (even mild constipation or feeding changes)
- Contact your doctor or go to the ER immediately if your infant appears weak, has trouble feeding, or shows signs of breathing difficulty
- Keep the can or lot number — it may be needed for medical or legal purposes
Multiple families have already filed lawsuits against ByHeart, alleging the contaminated formula caused their babies’ severe illness and hospitalization.
Health officials emphasize that while infant botulism remains rare, this is the first confirmed outbreak ever linked to powdered infant formula in the United States.
Parents with concerns about infant botulism or possible exposure should contact their pediatrician or local health department right away.
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