ByHeart tests find botulism bacteria; all lots may be contaminated
ByHeart said 5 of 36 product samples from three lots tested positive for Clostridium botulinum type A and that it “cannot rule out” contamination across all lots, triggering a nationwide Nov. 11 recall as at least 31 infants in 15 states have been sickened since August and at least 107 infants have received BabyBIG treatment. FDA and state officials say some recalled product remained on store shelves and that major retailers have been slow to remove it; regulators urge consumers to verify lot numbers and avoid any recalled product, and ByHeart has expanded refunds for purchases made on its website on or after Aug. 1.
📌 Key Facts
- ByHeart testing found 5 of 36 product samples from three lots positive for Clostridium botulinum type A, and the company said it "cannot rule out" contamination across all lots.
- At least 31 infants in 15 states have been sickened since August; some ByHeart-fed infants were treated as far back as November 2024 but are not counted in the current outbreak tally.
- At least 107 infants nationwide have received BabyBIG treatment since Aug. 1; a typical year sees fewer than 200 infant botulism cases.
- 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 indicate recalled items are still accessible in some retail channels, prompting renewed removal efforts.
- Regulators are warning consumers to verify lot numbers and avoid using any recalled product that may still be available for purchase.
- ByHeart expanded its refund policy so customers who bought on the company’s website on or after Aug. 1 can receive a full refund.
📊 Relevant Data
Hispanics and Asian families have a higher incidence of infant botulism because of their use of herbal medications and raw honey.
Diagnosing and Treating Infant Botulism — BioSupply Trends Quarterly
The prevalence of breastfeeding initiation is 74.5% among mothers identifying as Black, compared to 84.0% overall.
Disaggregation of Breastfeeding Initiation Rates by Race and Ethnicity — Preventing Chronic Disease - CDC
Black infants are breastfed less than other racial groups, leading to higher reliance on infant formula.
How the Baby Formula Shortage Disproportionally Affects Black and Low-Income Babies — George Mason University College of Public Health
📰 Sources (3)
- 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.