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Baby Formula Recall: What's Happening and Why It Matters

USAWednesday, November 12, 2025
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A significant recall is currently underway for ByHeart's organic baby formula following reports of infant botulism in multiple states. The recall now encompasses all of their products, not just specific batches.

Impact and Health Concerns

  • 15 babies in 12 states have fallen ill since August.
  • All affected babies were fed ByHeart formula and were hospitalized.
  • No deaths have been reported.

Investigation and Recall Details

  • ByHeart initiated a full recall despite tests on unopened cans showing no contamination.
  • The bacteria causing botulism is common in the environment, so contamination may not have originated from the formula itself.
  • California health officials detected the toxin in an open can of ByHeart formula given to a sick baby, prompting the FDA to recommend a wider recall.
  • The FDA is investigating 84 cases of infant botulism since August, with 15 linked to ByHeart formula.

Company Response and Safety Measures

  • ByHeart produces 200,000 cans of formula monthly, sold in major retailers like Target, Walmart, Albertsons, and Whole Foods.
  • The company is now testing every batch with an independent lab and granting health officials full access to their facilities.

Understanding Infant Botulism

  • Infant botulism is rare but serious, occurring when babies ingest bacteria that produce toxins in their gut.
  • Symptoms include:
  • Constipation
  • Poor feeding
  • Weak muscles
  • Trouble breathing
  • Immediate medical attention is required if symptoms appear.
  • Treatment involves BabyBIG, a special IV medicine.

Conclusion

ByHeart is collaborating closely with the FDA and taking extensive measures to ensure product safety. This recall highlights the critical importance of monitoring baby formula safety.

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