Multistate Infant Botulism Outbreak Linked to Recalled ByHeart Infant Formula
One case reported in Minnesota; health officials urge families to dispose of affected formula immediately
Published: November 11, 2025
MINNESOTA — Health officials in Minnesota and across the country are warning parents to check their infant formula after the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), and state health departments identified a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.
As of November 8, 2025, thirteen infants from ten states, including one case in Minnesota, have been diagnosed with suspected or confirmed infant botulism. All affected infants reportedly consumed ByHeart Whole Nutrition Infant Formula between August and November 2025. While no deaths have been reported, botulism is considered a serious illness that can cause difficulty breathing, muscle paralysis, and potentially death if untreated.
What Parents Should Know
Infant botulism often begins subtly, with constipation as an early symptom. As the toxin takes effect, symptoms may progress to include:
Trouble feeding, sucking, or swallowing
Weak or floppy movements and loss of head control
Weak or altered cry
Decreased facial expression
These symptoms can worsen over time and, in severe cases, may lead to breathing difficulties or respiratory failure. The CDC urges parents to seek immediate medical care if their child exhibits any of these signs after consuming ByHeart formula.
Recalled Products
On November 8, ByHeart Inc. issued a voluntary recall for two specific lots of its Whole Nutrition Infant Formula:
Lot 206VABP/251261P2 – “Use by 01 Dec 2026”
Lot 206VABP/251131P2 – “Use by 01 Dec 2026”
The lot number and expiration date are on the bottom of the formula container. The formula is sold online and in major retail stores nationwide. Additional lots may be added as the investigation continues.
Lot number and "use by date" can be found at the bottom of the container.
Guidance for Families, Retailers, and Child-Care Facilities
Health officials are advising the following steps:
Parents and caregivers: Do not feed infants any formula from the recalled lots. Dispose of it immediately or return it to the place of purchase.
Businesses and child-care facilities: Do not sell, serve, or use recalled formula. Clean and sanitize all surfaces, bottles, and utensils that may have come into contact with it.
If your child consumed the affected formula and has symptoms, record the lot information before discarding the product and contact your healthcare provider right away.
Health Officials Emphasize Limited Supply Impact
According to the CDC, ByHeart Whole Nutrition Infant Formula accounts for less than one percent of all formula sales in the United States, and the recall is not expected to create formula shortages.
Additional Information
Full details on the outbreak are available on the CDC’s “Infant Botulism Outbreak Linked to Infant Formula” page.
Information about botulism symptoms, treatment, and prevention is available on the Minnesota Department of Health’s Botulism webpage.
The FDA’s recall announcement provides further guidance for identifying and handling the affected products.
Health officials continue to monitor the situation closely as laboratory testing and traceback investigations progress. Parents are urged to remain alert to new recall updates and to contact their local health department with any concerns.
Written by: Will Wight
