Fifty-one infants across 19 states have been hospitalized after consuming ByHeart Whole Nutrition infant formula contaminated with Clostridium botulinum, the bacteria that causes botulism. All ByHeart products were recalled on November 11, 2025, yet the recalled formula continues to appear on shelves at major retailers, including Walmart, Target, and Kroger. If your infant consumed this formula and developed botulism, you may have legal options for compensation.
Wagner Reese represents families affected by product liability cases, including contaminated infant formula. With offices in Indianapolis, Carmel, Fort Wayne, West Lafayette, and Evansville, we help families pursue justice when manufacturers prioritize profits over safety.
Understanding the ByHeart Formula Recall
The outbreak investigation began in August 2025, when California’s Infant Botulism Treatment and Prevention Program reported an increase in cases among infants who consumed ByHeart formula. The CDC and FDA expanded their investigation in December 2025 to include all cases since ByHeart began production in March 2022, after determining contamination may have affected every product batch the company ever manufactured. Cases started appearing as early as December 2023, with illnesses occurring through December 2025, according to federal health officials.
Independent laboratory testing confirmed Clostridium botulinum Type A in five of 36 samples tested across three different production lots. This widespread contamination pattern prompted ByHeart to recall all infant formula cans and single-serve Anywhere Pack sticks sold nationwide and internationally. Despite the comprehensive recall, the FDA has confirmed reports of ByHeart products remaining on store shelves weeks after the recall announcement. The agency sent warning letters to Target, Walmart, Kroger, and Albertsons stores for failing to remove recalled products, noting some locations even offered discounted pricing on contaminated formula after the recall.
Health Risks and Symptoms of Infant Botulism
Infant botulism is a rare but serious illness occurring when babies ingest Clostridium botulinum spores. Once swallowed, these spores colonize the intestinal tract and produce neurotoxins that attack the nervous system. The condition requires immediate medical attention and hospitalization. Foodborne illness from contaminated products can have devastating consequences for vulnerable populations like infants.
Symptoms typically develop within 30 days of consuming contaminated formula, but they may take several weeks to appear. Parents should watch for these warning signs:
- Constipation is often the first symptom to appear
- Difficulty feeding with poor sucking and swallowing
- A weak or altered cry compared to normal
- Loss of head control and muscle weakness
- Breathing problems, paralysis, and potential respiratory distress
All affected infants in this outbreak required hospitalization and treatment with BabyBIG, a specialized antitoxin. While no deaths have been reported, affected infants range in age from 16 days to 264 days, approximately 2 weeks to 8 months old. The extended symptom timeline means parents who used the ByHeart formula should remain vigilant even if their infant appears healthy now.
Affected Products and Where They Were Sold
The recall encompasses all ByHeart Whole Nutrition Infant Formula products sold in the United States and internationally, including Guam and Puerto Rico. This includes both formula cans and single-serve Anywhere Pack sticks, regardless of batch number, lot code, or expiration date. The company cannot isolate contamination to specific production periods, so any ByHeart product purchased could be contaminated.
ByHeart formula was available online through the company’s website and at major retailers nationwide. The formula, marketed as an organic option, accounted for approximately 1% of the U.S. infant formula market and sold roughly 200,000 cans monthly before the recall. Parents purchased these products believing they were providing high-quality nutrition for their babies, only to discover the formula contained dangerous bacteria. Botulism from contaminated food products represents one of the most serious foodborne illnesses affecting infants.
Immediate Steps for Parents and Caregivers
If you have purchased ByHeart formula, stop using it immediately and dispose of all products. Check pantries, diaper bags, and any location where formula might be stored. Do not use any ByHeart products, even if they appear unopened or are from different lot numbers. Before discarding, photograph the lot number and expiration date on the packaging, as this documentation may be valuable if you pursue legal action.
Monitor your infant for any symptoms of botulism, particularly if they consumed ByHeart formula within the past 30 days. Symptoms can develop weeks after exposure, so continued observation is essential. If your infant shows any warning signs, such as constipation, feeding difficulties, weakness, or changes in crying, seek emergency medical care immediately and inform healthcare providers of the formula exposure.
For refunds, ByHeart offers full reimbursement for products purchased on their website after August 1, 2025. If you purchased the ByHeart formula at a retail store, contact the retailer directly for their refund policy. However, obtaining a refund does not prevent you from pursuing additional legal claims if your infant was harmed.
How Wagner Reese Can Help Affected Families
When a manufacturer sells contaminated infant formula that harms children, families have legal rights. Product liability law holds companies accountable when defective products cause injuries. ByHeart’s contamination represents a failure in manufacturing safety, resulting in preventable harm to dozens of infants. Our firm has experience handling cases involving dangerous products and the consequences they cause for Indiana families.
“From handling foodborne illness cases, we understand the devastating impact these outbreaks have on families,” says Jason Reese, co-founder and managing partner of Wagner Reese, a trusted Indiana personal injury law firm. “Parents trust that infant formula manufacturers follow strict safety protocols. When companies fail to protect the most vulnerable consumers, they must be held accountable for the consequences.”
If your infant consumed ByHeart formula and developed botulism, contact Wagner Reese today for a free consultation to discuss your situation and legal options.
