ByHeart Iowa – Where your Botulism Infant Formula was likely Manufactured

Inspection Report 2025 (Exhibits not provided) – “At the close-out of the inspection, a Form FDA 483, Inspectional Observations, was issued for 3 items, along with a ‘Additional Observations,’ and 7 ‘General Discussion with Management. The three 483 items included, receiving, and releasing ___________ ingredient used in infant formula has powder that was not held under conditions to prevent adulteration, not taking actions to eliminate all potential harborage areas when issues with rodent arose during the year 2024-2025; not monitoring the floor conditions adequately at the dryer ____ (level __ and level __) when there were findings of confirmed Cronobacter Sakazakii.” ” The two additional observations consists of the firm not having clear barriers separating hygiene zones; and not monitoring bathhouse differential pressures.”

483 2025 – “Observation 1: You approved and released for use an ingredient that was not manufactured, packages, labeled, or held under conditions to prevent adulteration.” “Observation 2: You did not exclude pests from your food plant to protect against contamination of food.” “Observation 3: You did not maintain a building used in the manufacture, processing, packing or holding infant formula in a clean and sanitary condition.”

As of November 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 17 states – Arizona 3, California 5, Idaho 1, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 3, Pennsylvania 1, Rhode Island 1, Texas 8, Washington 2 and Wisconsin 1. Laboratory confirmation for some cases is ongoing. For 36 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 19, 2025. All 37 infants were hospitalized. No deaths have been reported to date. For 35 infants with age and sex information available, they range in age from 16 to 264 days and 15 (43%) are female. 

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.