Federal health officials have launched an urgent investigation after 13 infants across 10 states were hospitalized with botulism linked to ByHeart Whole Nutrition Infant Formula, triggering a sweeping recall and raising alarm among parents nationwide.
Botulism Outbreak Linked to ByHeart Formula
The crisis began when clusters of infant botulism cases surfaced in states including
Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All affected infants had consumed formula from two specific lots:
206VABP/251261P2 and 206VABP/251131P2, both marked with a "Use by 01 Dec 2026" date.
Botulism is a rare but potentially life-threatening illness caused by toxins produced by the bacterium
Clostridium botulinum. In infants, symptoms can include
poor feeding, loss of head control, difficulty swallowing, and decreased facial expression—signs that may take weeks to develop, making early detection challenging.
FDA and CDC Respond: What Parents Need to Know
The
FDA and CDC are working with state health departments to determine how the contamination occurred and whether other products are at risk. So far,
no deaths have been reported, but all 13 infants required hospitalization.
Health officials urge parents to:
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Check formula lot numbers before discarding or returning products.
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Clean all items and surfaces that came into contact with the recalled formula using hot, soapy water or a dishwasher.
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Seek immediate medical care if their infant shows symptoms after consuming the recalled formula.
The CDC estimates ByHeart's recalled product accounted for about
1% of national formula sales, meaning the risk, while serious, is relatively contained.
Inside the Investigation: How Did This Happen?
The FDA is investigating the source of contamination and whether other batches or brands could be affected. ByHeart, a company known for its direct-to-consumer and retail formula sales, has not yet commented publicly on the recall or the outbreak's cause.
Experts note that
botulism cannot be detected by taste or smell, making it especially dangerous in foods like infant formula. The illness is rare, but its severity demands swift action and transparency.
What This Means for Families and the Industry
This recall comes at a time when
formula safety is under intense scrutiny, following previous supply chain disruptions and recalls. For parents, the incident is a stark reminder to
stay vigilant about product safety and recall alerts.
For the formula industry, the outbreak highlights the need for
stricter quality controls and rapid response protocols. Regulators are expected to push for more robust testing and traceability measures in the wake of this incident.
Actionable Takeaways
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If you have ByHeart formula: Check the lot number immediately. If it matches the recalled lots, dispose of it safely and clean all feeding equipment.
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Monitor your infant: Watch for symptoms of botulism, even if exposure was weeks ago.
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Stay informed: Follow updates from the FDA, CDC, and your state health department for the latest guidance.
As the investigation unfolds, parents and caregivers are urged to prioritize safety and consult healthcare providers with any concerns. The ByHeart recall is a sobering reminder of the importance of vigilance in infant nutrition.
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1. ByHeart formula recall linked to infant botulism cases in 10 states ...
2. Infant Botulism in 10 US States Linked to Formula Being Recalled
3. FDA Announces Recall of ByHeart Whole Nutrition Infant Formula Due to Outbreak of Infant Botulism
4. Ten US states report infant botulism cases linked to recalled formula
5. Outbreak Investigation of Infant Botulism: Infant Formula - FDA
6. Baby formula recalled after Illinois infants have botulism symptoms, health department says
7. California Alerted CDC of Multistate Infant Botulism Outbreak Linked ...
8. Baby formula recalled after reports of infant botulism in 10 U.S. states
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11. Baby Formula news - Today's latest updates
12. Food Safety News: Home
13. ByHeart baby formula recalled after infant botulism outbreak in US
