Update: ByHeart Infant Formula Botulism Outbreak Investigation Continues
November 14, 2025: At least 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula have been reported from 13 states, with all 23 requiring hospitalization. Illnesses began between August 9 and November 11, 2025, and while laboratory confirmation is ongoing for some cases, preliminary tests from the California Department of Public Health detected Clostridium botulinum in an open can from lot 206VABP/251131P2. The FDA and CDC, working with state partners, continue the investigation through onsite inspections, sample collection, and additional testing to identify the contamination source [5].
ByHeart Infant Formula Recall: Scope and Impact
ByHeart expanded its voluntary recall on November 10, 2025, to include all Whole Nutrition Infant Formula in 24-oz cans and Anywhere Pack pouches after FDA investigations linked 15 hospitalizations to the product. The outbreak, involving 84 suspected cases, shows ByHeart’s 1% market share disproportionate to its 15 confirmed cases. No deaths occurred, but the recall covers 200,000 monthly cans sold at Target, Walmart, and online [1].
The company’s Iowa production and Oregon canning facilities are under FDA scrutiny. Similar recalls, like the 2022 Abbott crisis, exposed supply chain weaknesses, but botulism’s rarity in formula makes this case particularly alarming. Parents are urged to switch to alternatives while awaiting refunds.
Affected ByHeart Products
The recall includes:
■ ByHeart Whole Nutrition Infant Formula: 24-oz cans for 0–12 months, all lots since 2022.
■ ByHeart Anywhere Pack Pouches: Portable powder packets, all varieties.
Check labels for “ByHeart” branding and return to retailers.
Botulism Risks from Contaminated Formula
Infant botulism arises when Clostridium botulinum spores germinate in a baby’s immature gut, releasing toxin that paralyzes muscles. Symptoms include constipation, weak suck, and breathing issues. The condition affects ~100 U.S. infants yearly, with 90% hospitalization [2].
ByHeart’s organic process may have allowed spore entry from environmental sources. The recall’s breadth reflects caution, as unopened testing was negative but mixing activates risks.
Symptoms of Infant Botulism
Affected babies may show:
■ Early Signs: Constipation or poor feeding within days to weeks.
■ Muscle Weakness: Drooping eyelids, limp limbs, or weak cry.
■ Severe Effects: Difficulty swallowing or breathing, needing ventilation.
■ Recovery: With BabyBIG antitoxin, most recover, but hospital stays last weeks.
Costs reach $50,000–$100,000 per case for antitoxin and care [3].
Recall Remedy and Consumer Steps
The FDA and ByHeart advise:
- Stop using all ByHeart formula immediately.
- Return cans or pouches to retailers for refunds.
- Clean bottles and surfaces to prevent contamination.
- Consult a pediatrician if symptoms appear.
ByHeart emails buyers and posts alerts. Refunds are immediate, but document purchases for potential ByHeart Infant Formula Recall Class Action Lawsuit claims.
Potential for a ByHeart Infant Formula Recall Class Action Lawsuit
The recall of all ByHeart formula, linked to 15 hospitalized infants, provides grounds for a ByHeart Infant Formula Recall Class Action Lawsuit against the company. Potential claims include:
■ Product Liability: Defective production allowed spore contamination.
■ Negligence: Inadequate facility sanitation or testing.
■ Failure to Warn: Insufficient alerts about botulism risks.
■ Breach of Warranty: Formula unfit for safe infant nutrition.
Plaintiffs may seek compensation for medical expenses ($50,000–$100,000 per case), emotional distress, and punitive damages. The recall’s scope—200,000 cans monthly—suggests a large class, similar to the 2022 Abbott recall, which settled for $15 million. A successful ByHeart Infant Formula Recall Class Action Lawsuit could mandate spore testing for powdered formulas and enhanced FDA oversight for new entrants.
Do I Have a ByHeart Infant Formula Recall Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers focusing on infant formula recall lawsuits. We are handling individual litigation nationwide and currently accepting new botulism exposure cases in all 50 states.
Free ByHeart Infant Formula Recall Class Action Lawsuit Evaluation: If your child consumed ByHeart formula and experienced botulism symptoms or hospitalization, you should contact our law firm immediately. You may be entitled to compensation by filing a ByHeart Infant Formula Recall Class Action Lawsuit, and our lawyers can help.
References
- https://apnews.com/article/byheart-baby-formula-infant-botulism-recall-e070565daaf1f425e3d37dca20277714
- https://www.cdc.gov/botulism/infant-botulism.html
- https://www.mayoclinic.org/diseases-conditions/infant-botulism/symptoms-causes/syc-20370262
- https://www.fda.gov/news-events/press-announcements/fda-investigates-infant-botulism-outbreak-linked-infant-formula
- https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025