Harrisburg, PA ─ The Pennsylvania Department of Health (DOH) is alerting Pennsylvanians that there are 13 cases across 10 states of infant botulism connected to ByHeart Whole Nutrition Infant Formula, a milk-based powder formula with iron for children birth to 12 months.
One Pennsylvania infant, who reportedly consumed the ByHeart formula, was hospitalized in October and is recovering.
DOH is supporting an ongoing investigation by the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), along with other states.
Parents and caregivers should stop using the following lot numbers with “use by” dates of December 1, 2026, found on the bottom of the can. Please see the FDA website for information on what to do with formula from these lots.
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
According to the FDA, ByHeart Whole Nutrition Infant Formula makes up less than 1% of all infant formula sold in the United States.
Infant botulism occurs when spores of Clostridium botulinum are ingested and grow in the intestines of infants, usually under one year of age. Infant botulism is a serious condition and can be fatal. Signs and symptoms can appear slowly and gradually get worse over time.
If your child is experiencing signs or symptoms of botulism, such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate medical assistance. Learn more about the signs, symptoms, and next steps to take on the CDC website.
The FDA investigation is ongoing to determine the point of contamination and if any other products are impacted. Updated information about the investigation and any further product recalls will be shared through the FDA website.
# # #