ByHeart tests find botulism bacteria; all lots may be contaminated
ByHeart reported that 5 of 36 product samples from three lots tested positive for Clostridium botulinum type A and said it "cannot rule out" contamination across all lots, prompting a Nov. 11 nationwide recall that FDA and state officials say has not been fully pulled from some store shelves; ByHeart has expanded refunds for website purchases on or after Aug. 1. Public health authorities have linked the formula to an outbreak — at least 31 infants in 15 states sickened since August and at least 107 infants treated with BabyBIG nationwide — and an Oregon baby remains critically ill with laboratory‑confirmed infant botulism after consuming ByHeart formula.
đź“Ś Key Facts
- ByHeart reported 5 of 36 product samples from three lots tested positive for Clostridium botulinum type A and said it "cannot rule out" contamination across all lots.
- ByHeart issued a nationwide recall on Nov. 11, but some recalled product remained on store shelves afterward.
- The FDA says major retailers have been slow to remove the recalled infant formula; compliance checks found recalled items still accessible in some retail channels, prompting renewed removal efforts and warnings to consumers to verify lot numbers and avoid using any recalled product.
- At least 31 infants in 15 states have been sickened since August; some ByHeart-fed infants were treated as far back as November 2024 and were not counted in the outbreak total.
- At least 107 infants nationwide have received BabyBIG treatment since Aug. 1; by comparison, a typical year sees fewer than 200 infant botulism cases.
- An Oregon infant is still critically ill with laboratory‑confirmed infant botulism after consuming ByHeart formula; the case involves prolonged hospitalization, treatment and complications, and family members and clinicians described the rapid onset and progression of symptoms.
- ByHeart expanded its refund policy, offering a full refund to customers who purchased on the company website on or after Aug. 1.
đź“Š Relevant Data
This is the first documented outbreak of infant botulism linked to contaminated infant formula in the United States.
CDC's Rapid Response Helps Solve First Infant Botulism Outbreak Linked to Formula — CDC
In California, from 2011 to 2017, 84.2% of infant botulism cases were among White infants, compared to approximately 26.7% of births being White (2021-2023 average), indicating overrepresentation; 29.4% of cases were Hispanic compared to 47.9% of births, indicating underrepresentation; 8.9% Asian compared to 15.6% of births; 2.8% African American compared to 4.8% of births.
Descriptive Epidemiology of Infant Botulism in California — ScienceDirect
Breastfeeding continuation rates at 6 months in the US (based on 2018-2022 data) are 51.7% for Non-Hispanic Black infants, 52.3% for American Indian/Alaska Native, 58.7% for Hispanic, 63.5% for Non-Hispanic White, and 73.9% for Non-Hispanic Asian, leading to varying reliance on infant formula.
Comparing New CDC Breastfeeding Rates to Healthy People 2030 Breastfeeding Targets — USBC News & Blogs
The national incidence of infant botulism in the US is approximately 1.9 cases per 100,000 live births, with higher rates in the West (6.0 per 100,000) and Northeast (4.9 per 100,000) regions.
Infant Botulism on the Rise; an Outbreak in the US — rapidmicrobiology.com
đź“° Source Timeline (4)
Follow how coverage of this story developed over time
- Profiles an Oregon infant who is still critically ill with laboratory‑confirmed infant botulism after consuming ByHeart formula, giving a concrete, ongoing case rather than aggregate counts.
- Details the child’s clinical course (prolonged hospitalization, treatment, complications) that illustrates the severity of ByHeart‑linked illness beyond the aggregate CDC numbers Twin Cities readers have already seen.
- Includes new quotes from the family and treating clinicians on symptoms, timing and how quickly the baby declined after exposure, adding human and medical specificity to the risk previously described only statistically.
- FDA says major retailers have been slow to remove recalled infant formula from store shelves following the ByHeart recall.
- Regulators are warning consumers to verify lot numbers and avoid using any recalled product that may still be available for purchase.
- The agency indicates compliance checks show recalled items still accessible in some retail channels, prompting renewed removal efforts.
- ByHeart reported 5 of 36 product samples from three lots tested positive for Clostridium botulinum type A and said it 'cannot rule out' contamination across all lots.
- Outbreak status: at least 31 infants in 15 states have been sickened since August; some ByHeart-fed infants were treated as far back as Nov. 2024 (not counted in the outbreak).
- Despite the Nov. 11 nationwide recall, some product remained on store shelves, according to FDA and state officials.
- At least 107 infants nationwide have received BabyBIG treatment since Aug. 1; a typical year sees fewer than 200 infant botulism cases.
- Refund policy expanded: customers who bought on ByHeart’s website on or after Aug. 1 can receive a full refund.