by Sacramento, California – A nationwide recall has been issued for ByHeart Whole Nutrition Infant Formula after a botulism outbreak sickened more than a dozen infants across ten U.S. states, prompting an urgent investigation by federal and state health agencies.
Infant Botulism Outbreak Triggers Recall
The California Department of Public Health (CDPH) confirmed that its Infant Botulism Treatment and Prevention Program detected an unusual rise in cases earlier this year. Testing by the state’s public health laboratory found traces of Clostridium botulinum, the bacteria responsible for infant botulism, in a sample of ByHeart powdered formula.
Officials have identified 13 suspected or confirmed cases across 10 states since August, with eight confirmed as type A botulism — a rare but serious form of the illness.
“We are urging parents to stop using ByHeart formula immediately,” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “Our preliminary tests show positive results for the bacteria linked to these cases.”
Product Details and Retail Recall
The recall affects two specific production lots of ByHeart Whole Nutrition Infant Formula:
- Lot #206VABP/251261P2
- Lot #206VABP/251131P2
Both containers are marked with a “Use by 01 Dec 2026” date.
The recalled formula was sold both online through ByHeart’s official website and in stores nationwide, including Amazon, Target, Walmart, Whole Foods, and Kroger.
ByHeart Inc. issued the recall notice on November 8, emphasizing that it is working closely with the CDC, FDA, and CDPH to identify how the contamination occurred and to prevent further spread.
Understanding Infant Botulism
Infant botulism occurs when babies ingest spores of Clostridium botulinum, which then produce toxins inside the body. The condition can cause muscle weakness, difficulty feeding, constipation, and in severe cases, respiratory failure if not treated promptly.
“Infant botulism is a very rare disease, but early treatment is critical,” Dr. Pan added. “Babies can fully recover with rapid medical intervention.”
Symptoms to watch for include:
- Weak or floppy muscles
- Constipation or poor feeding
- Weak cry and poor head control
- Reduced facial expression
Parents noticing these signs should seek immediate medical attention and inform healthcare providers about the recalled formula.
What Parents Should Do
The CDPH and FDA are advising families to:
- Stop using the recalled formula immediately.
- Keep the packaging (including the lot number) for investigation.
- Contact healthcare providers if their child shows symptoms.
- Report potential cases to local health departments for testing and tracking.
Physicians treating suspected cases can reach California’s Infant Botulism Treatment and Prevention Program at (510) 231-7600 for consultation and treatment guidance.
National Response and Supply Impact
The U.S. Food and Drug Administration (FDA) emphasized that ByHeart’s product makes up less than 1% of the national infant formula supply, meaning the recall is not expected to cause widespread shortages.
Officials are continuing to investigate the source of contamination and whether other batches may have been affected. Updates and detailed recall information are available through the CDPH and FDA websites.
Has your family been affected by this formula recall or seen shortages in your area? Share your experience in the comments at mikeandjonpodcast.com.
