ByHeart tests find botulism bacteria; all lots may be contaminated
ByHeart has recalled all of its baby formula nationwide after tests found 5 of 36 samples from three lots positive for Clostridium botulinum type A and the company said it "cannot rule out" contamination across all lots. The outbreak has sickened at least 31 infants in 15 states since August (with some ByHeart-fed infants treated as far back as Nov. 2024), at least 107 infants have received BabyBIG treatment since Aug. 1, regulators say some product remained on shelves despite the Nov. 11 recall, and ByHeart has expanded refunds to customers who bought from its website on or after Aug. 1.
📌 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.
- At least 31 infants in 15 states have been sickened since August; some ByHeart-fed infants were treated as far back as November 2024 (not counted in the outbreak tally).
- At least 107 infants nationwide have received BabyBIG antitoxin treatment since Aug. 1.
- A typical year sees fewer than 200 infant botulism cases nationwide, underscoring the scale of recent treatments and illnesses.
- Despite a nationwide recall issued Nov. 11, FDA and state officials reported that some ByHeart product remained on store shelves.
- ByHeart expanded its refund policy: customers who bought product on the company’s website on or after Aug. 1 can receive a full refund.
📰 Sources (2)
ByHeart baby formula from all lots may be contaminated with botulism bacteria, tests show
New information:
- 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.