Federal health officials have reported 51 cases of infant botulism linked to ByHeart Whole Nutrition formula across 19 states. The U.S. Food and Drug Administration (FDA) has issued warning letters to four major retailers for allegedly continuing to sell the formula after a recall was initiated. No fatalities have been reported.
Outbreak Scope and Timeline
The outbreak includes 51 suspected or confirmed cases of infant botulism in 19 states. The FDA expanded its case definition to include any infant diagnosed with botulism who consumed ByHeart formula since the company began production in March 2022.
- The most recent illness was reported on December 1.
- All affected infants were hospitalized and received intravenous treatment.
- No fatalities have been associated with the outbreak.
- Under the expanded definition, 12 additional cases were identified, including two within the original timeline and ten from December 2023 through July 2025.
Previously, the FDA had confirmed 31 cases involving infants who consumed the formula between August and mid-November. This initial count followed an increase in treatments reported by California's Infant Botulism Treatment and Prevention Program.
Affected States
Cases have been reported in:
- Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington
- Four additional states were identified under the expanded case definition.
Recall Actions
ByHeart Whole Nutrition initially recalled two batches of its infant formula in early November. On November 11, the company expanded the recall to include all of its products.
The formula products (cans and single-serve packets) are distributed nationwide through retailers including Target, Publix, Walmart, Whole Foods, and online platforms. Some products were shipped to international customers.
ByHeart holds approximately 1% of the U.S. infant formula market and sold about 200,000 cans monthly. The FDA has not expressed concerns about a potential supply shortage.
Investigation
- The California Department of Public Health tested a sample from one recalled batch and confirmed the presence of Clostridium botulinum.
- ByHeart reported that independent laboratory tests indicated 36 samples from three distinct lots contained the bacteria associated with infant botulism.
- A ByHeart FAQ states that third-party testing identified the bacteria in samples of unopened formula.
- FDA inspectors conducted visits to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. Inspection results have not been publicly released.
Dr. Jennifer Cope, a CDC scientist leading the investigation, indicated that the contamination appeared to be persistent across various production runs, lots, and raw material batches.
Previous Regulatory Issues
- In 2022, ByHeart recalled five batches of infant formula after a sample tested positive for Cronobacter sakazakii.
- In 2023, the FDA issued a warning letter to ByHeart detailing outstanding corrective actions.
- A ByHeart plant in Reading, Pennsylvania, was temporarily closed in 2023 prior to FDA inspectors discovering mold, water leaks, and insects.
Retailer Warning Letters
The FDA issued warning letters dated December 12 to Walmart, Target, Kroger, and Albertsons. The letters allege that these retailers continued to sell ByHeart formula for periods ranging from days to weeks after the November 11 recall.
FDA Findings
- Target: Formula was reportedly present in stores across 20 states after the recall. Instances included a sale in New Hampshire on November 16, despite an electronic sales block, and promotional offers for single-serve packs in an Arkansas store between November 16 and November 22.
- Walmart: Formula was documented in stores across 21 states from November 12 to November 26.
- Albertsons: Formula was found in stores in 11 states between November 12 and November 19.
- Kroger: Formula was identified in stores in 10 states from November 12 to November 19.
The FDA stated that the companies failed to provide evidence of corrective actions despite multiple requests. The retailers have been given 15 working days to respond.
Company Responses
- Walmart stated that no ByHeart formula was sold after cash registers were blocked following the recall. A spokesperson said, "We moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online," and confirmed the company would respond to the letter.
- Albertsons stated it collaborated with suppliers and regulators to identify and remove products and inform customers, adding that "ByHeart infant formula products have been removed from our store shelves."
Information Distribution Concerns
Steven Mandernach, Executive Director of the Association of Food and Drug Officials (AFDO), noted that the FDA did not fully share product lists with state and local food safety officials until November 14, nearly a week after the initial recall of two lots on November 8.
Infant Botulism Information
Infant botulism is a rare illness caused by Clostridium botulinum spores. Upon ingestion by an infant, the spores proliferate in the gut and produce toxins. Infants under one year of age are particularly vulnerable due to their immature gut microbiomes.
Symptoms typically manifest three to 30 days after consumption and may include:
- Constipation
- Diminished feeding
- Difficulty swallowing
- Loss of head control
- Drooping eyelids
- Flat facial expression
- Generalized weakness (floppy appearance)
- Difficulty breathing
Untreated, the illness can lead to progressive, flaccid paralysis and may require weeks of hospitalization. Treatment involves an intravenous antitoxin called BabyBIG, which is manufactured exclusively by California's infant botulism program.
Guidance for Parents
The Centers for Disease Control and Prevention (CDC) advises parents to monitor infants for symptoms for several weeks after their last consumption of ByHeart formula. Recommendations include:
- Clean and sanitize contaminated surfaces.
- Label remaining formula powder "DO NOT USE" and store securely for one month for potential testing by state health departments.
- Seek immediate medical attention if concerning symptoms arise.
The California Department of Public Health has established an infant botulism outbreak hotline.
ByHeart advises consumers to stop using the formula and has enhanced customer resources, including a 24/7 support hotline and refunds for purchases made since October. The company has committed to implementing more robust safeguards and testing.
Legal Actions
- Separate federal lawsuits have been filed by the parents of two four-month-old infants in Arizona and Kentucky. The lawsuits allege negligence by ByHeart and seek compensation for medical expenses and emotional distress.
- A class-action lawsuit filed in New York alleges deceptive marketing practices.
- Families of several other infants have initiated additional lawsuits against the company.
ByHeart declined to comment on the lawsuits, stating its focus is on ensuring recall awareness and supporting the FDA investigation.