What We Know About the ByHeart Infant Formula Botulism Outbreak
This is the first-ever outbreak of infant botulism linked to powdered infant formula in the United States. As of February 26, 2026, 48 infants across 17 states were included in CDC’s final outbreak count after consuming ByHeart Whole Nutrition Infant Formula contaminated with Clostridium botulinum Type A spores.
All 48 infants required hospitalization and treatment with BabyBIG (Botulism Immune Globulin Intravenous), a specialized antitoxin. No deaths have been reported. The affected infants ranged from 16 to 264 days old.
How the Outbreak Was Discovered
The California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program (IBTPP) first identified a surge in infant botulism cases and notified the CDC on November 7, 2025. Within 24 hours, the CDC and FDA contacted ByHeart. On November 8, CDPH preliminarily detected botulinum toxin Type A in an open can of ByHeart formula fed to a diagnosed infant.
The CDC typically sees 150 to 180 individual (sporadic) cases of infant botulism per year. A multi-case outbreak linked to a single product is unprecedented.
The Contamination Source
FDA and ByHeart testing confirmed Clostridium botulinum Type A in multiple formula samples. Whole genome sequencing matched isolates from the finished formula to the organic whole milk powder ingredient, definitively identifying the contamination source.
The organic whole milk powder was:
- Supplied by Organic West Milk Inc. (California)
- Processed at a Dairy Farmers of America plant in Fallon, Nevada
- Organic West stated it did not supply the powder to any other infant formula maker
ByHeart tested 36 finished product samples and found 6 positive for C. botulinum Type A across batches 251261P2, 251131P2, and 251481P2. The FDA independently collected 8 positive samples.
The Recall
- November 8, 2025: ByHeart voluntarily recalled two specific batches (251261P2 and 251131P2)
- November 11, 2025: Recall expanded to ALL ByHeart formula products, all lot numbers, all formats
Despite the recall, the FDA found recalled formula still on store shelves at more than 175 locations across 36 states. On December 12, 2025, the FDA sent warning letters to Target, Walmart, Kroger, and Albertsons for failing to remove recalled products. Target had even offered a $2.00 promotional discount on recalled formula from November 16-22.
ByHeart’s History of Safety Failures
This is not ByHeart’s first contamination issue:
- December 2022: Recalled 5 batches after a sample tested positive for Cronobacter sakazakii. ByHeart’s root cause analysis incorrectly blamed “a laboratory error.”
- August 2023: FDA issued a warning letter for the Reading, Pennsylvania facility citing over 2,700 dead insects in a food production area, mold inside water tanks, recurring roof leaks, temperature control failures, and inadequate sanitation. The facility shut down in September 2023.
Your Legal Rights
If your infant consumed ByHeart formula and was diagnosed with or showed symptoms of infant botulism, your family may be entitled to compensation for medical expenses, hospitalization costs, pain and suffering, and other damages. Infant botulism treatment requires specialized care, and hospitalization typically lasts weeks.
Ron Simon & Associates has recovered over $850 million for food poisoning victims nationwide. Our team has an exclusive focus on foodborne illness litigation and is actively investigating this outbreak. You pay us nothing unless we win your case.
What You Should Do Now
- Stop feeding your infant ByHeart formula immediately and switch to a different brand
- Watch for symptoms: constipation, poor feeding, weak cry, loss of head control, difficulty swallowing, muscle weakness
- Seek immediate medical attention if your infant shows any symptoms
- Save any remaining formula and packaging as evidence
- Contact us for a free, confidential case evaluation at 1-888-335-4901