Staff Reporter | iSkyNews.com (ISC News)
Published November 29th, 2025
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Infant Formula Recall Expands as CDC Investigates Multistate Infant Botulism Outbreak
PHOENIX, AZ (iSkyNews.com) — Federal and state health officials are urgently warning parents and caregivers about a multistate infant botulism outbreak linked to ByHeart Whole Nutrition Infant Formula, prompting a nationwide recall and ongoing investigation.
The CDC, the U.S. Food and Drug Administration (FDA), multiple state health departments, and the California Department of Public Health Infant Botulism Treatment and Prevention Program are coordinating efforts after identifying a growing number of infant botulism cases.
Outbreak Overview
- Cases: 37 (including 6 new cases)
- Hospitalizations: 37
- Deaths: 0
- States affected: 17 (2 newly added)
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| Photo Credit: CDC |
Every child affected so far has required hospitalization.
Infant botulism occurs when infants ingest Clostridium botulinum spores, which can grow inside the gut and produce toxins. Early signs typically include constipation, but many caregivers first notice poor feeding, weak cry, reduced facial expression, or loss of head control.
Recall Information
On November 11, 2025, ByHeart Inc. issued a full recall of all its infant formula products, including:
- All lot numbers
- All can sizes
- All single-serve packet sizes
The recalled formula was sold online and through major retailers nationwide.
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| Photo Credit: CDC |
What Parents and Caregivers Should Do
- Stop using all ByHeart Whole Nutrition Infant Formula immediately.
- Photograph or write down the lot number and expiration date if possible.
- If you still have unused formula:
- Label it clearly: “DO NOT USE.”
- Store it safely for at least 30 days.
- State health officials may request the remaining formula for testing if your infant develops symptoms.
- If no symptoms appear after a month, discard the formula.
- Thoroughly wash and sanitize any surfaces, bottles, scoops, or items that may have come into contact with the powdered formula.
Seek emergency medical care immediately if your infant has consumed ByHeart formula and shows:
- Poor feeding
- Trouble swallowing
- Constipation
- Loss of head control
- Decreased facial expression
- Weak or altered cry
Symptoms can take several weeks to appear, so continued monitoring is important.
The California Department of Public Health has set up a daily hotline for caregivers:
📞 1-833-398-2022 (available 7 a.m. – 8 p.m. PST)
To report adverse events or concerns, visit the FDA Safety Reporting Portal — but seek medical care first if symptoms are present.
Guidance for Businesses
- Remove all ByHeart Whole Nutrition Infant Formula from sale or use immediately.
- Wash and sanitize shelves, storage areas, and equipment that may have contacted recalled formula.
Guidance for Clinicians
- Diagnosis of infant botulism is based on clinical symptoms, not waiting for lab confirmation.
- For immediate consultation, contact the Infant Botulism Treatment and Prevention Program at
- 📞 510-231-7600 (available 24/7)
- Treatment with BabyBIG® is recommended for all suspected cases.
- Infant botulism is a notifiable disease and must be reported to the state public health department.
If untreated, infants may develop progressive, flaccid paralysis, including respiratory failure requiring prolonged hospitalization.
Health officials urge parents, caregivers, retailers, and healthcare providers to take the recall seriously and remain vigilant as the investigation continues.
Stay tuned to iSkyNews.com — your local Arizona news leader.
Source: CDC
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