The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local public health departments are investigating a multistate outbreak of infant botulism lined to recalled powdered infant formula. Epidemiologic data shows that 40% of formula-fed infants that received treatment for infant botulism consumed ByHeart brand powdered infant formula. Epidemiologic data show that ByHeart Whole Nutrition formula might be contaminated with Clostridium botulinum and is making infants sick. ByHeart Inc. has voluntarily recalled all lots of ByHeart Whole Nutrition Infant Formula cans and single-serve packets nationwide. Parents and caregivers should immediately stop using all ByHeart Whole Nutrition infant formula cans or single-serve packets.
As of November 19, 2025, 31 cases of suspected or confirmed infant botulism who consumed ByHeart powdered infant formula have been reported to the CDC across 15 states: Arizona (3), California (4), Idaho (1), Illinois (2), Kentucky (1), Maine (1), Michigan (1), Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (6), and Washington (2). All 23 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. At this time there are no cases of infant botulism from West Virginia linked to this outbreak.
For more information call the Wheeling-Ohio County Health Department at (304) 234-3682.
Wheeling-Ohio County Health Department
1500 Chapline Street, Room 106
Wheeling, WV 26003
(Get Directions)
Howard Gamble, MPH, LHA
Administration
(304) 234-3682
(304) 830-0420
[email protected]
Elizabeth Fowler, MSN, RN, BSN
Nursing Director
(304) 234-3682
[email protected]
Lock Johnson, RS
Chief Inspector-Environmental
(304) 234-3682
[email protected]
Savannah Lowe, MS, RD, LD
Nutrition Director
(304) 234-3888
[email protected]
Wayland Harris, EMT-P
Threat Preparedness Director
(304) 234-3682
[email protected]
Amy Martinkosky, BS, MA
Project HOPE Coordinator
(304) 234-3682
(740) 312-5777
[email protected]
Faith Gandy, MPH
Regional Epidemiologist
(304) 234-3682
[email protected]
Posted 11/10/25
Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing. Product: Certain lots of ByHeart Whole Nutrition Infant Formula: Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”) Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”) The lot code and “Use by” date are located on the bottom of the infant formula can. ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States and th...
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