Tests point to powdered whole milk as likely ByHeart botulism source
Laboratory testing and supply‑chain investigations have traced powdered whole milk used in ByHeart’s formula as a likely source of Clostridium botulinum, with the company saying 5 of 36 product samples from three lots tested positive for type A and that it “cannot rule out” contamination across all lots, prompting a nationwide recall that investigators say remains on some store shelves as retailers work to remove it. The outbreak has sickened at least 31 infants in 15 states (with additional earlier ByHeart‑linked cases), more than 107 infants have received BabyBIG treatment since Aug. 1, and individual patients — including an Oregon infant still critically ill — underscore the severity of the contamination; ByHeart has expanded refunds for certain online purchases.
📌 Key Facts
- 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.
- Investigators’ testing now points to powdered whole milk used in ByHeart formula as a likely source or vector of the contamination, and reporting describes how that powdered milk entered the company’s supply chain and the processing stage where contamination is suspected to have occurred.
- Experts say the ingredient-level finding raises questions about broader formula-safety standards and oversight of powdered dairy inputs.
- Outbreak tallies and treatment numbers: at least 31 infants in 15 states have been sickened since August (with some ByHeart-fed infants treated as far back as Nov. 2024 and not counted in the outbreak), and at least 107 infants nationwide have received BabyBIG treatment since Aug. 1 — in the context of a typical year that sees fewer than 200 infant botulism cases.
- Reporting profiles an Oregon infant who remains critically ill with laboratory-confirmed infant botulism after consuming ByHeart formula, detailing prolonged hospitalization, treatments and complications and including new quotes from the family and treating clinicians about the baby’s symptoms and rapid decline.
- Despite a Nov. 11 nationwide recall and an expanded refund policy for customers who bought on ByHeart’s website on or after Aug. 1, FDA and state officials say major retailers have been slow to remove recalled formula; compliance checks found recalled items still accessible in some retail channels, prompting renewed removal efforts and regulators’ warnings that consumers should verify lot numbers and avoid using any recalled product still available for purchase.
📊 Relevant Data
From 2000 to 2019, non-Hispanic Black infants represented 2.8% of infant botulism cases in the US, compared to approximately 13.9% of live births (2021-2023 average), indicating underrepresentation; Hispanic infants represented 24.9% of cases compared to 25.3% of births, indicating proportional representation.
Infant botulism incidence is elevated in regions with specific soil types such as Alfisols (40% of cases on 33% of land area) and Ultisols (33% of cases on 41% of land area), associated with neutral pH and coarse particles that favor Clostridium botulinum spore growth and dispersal.
In February 2022, Abbott Nutrition voluntarily recalled powdered infant formulas due to potential contamination with Cronobacter sakazakii, following reports of illnesses in infants, which contributed to a national formula shortage.
Cronobacter Outbreak Linked to Powdered Infant Formula — CDC
📰 Source Timeline (5)
Follow how coverage of this story developed over time
- Investigators’ testing now points to powdered whole milk used in ByHeart formula as a likely source or vector of the Clostridium botulinum contamination.
- The reporting explains how the powdered whole milk entered the ByHeart supply chain and at what stage in processing contamination is now suspected to have occurred.
- Experts quoted in the piece discuss what this ingredient‑level finding means for broader formula‑safety standards and for oversight of powdered dairy inputs.
- 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.