Federal health officials are investigating an outbreak of infant botulism linked to two batches of powdered infant formula, and they are urging immediate action from parents and caregivers as the recall takes effect, underscoring the need for vigilance in infant-nutrition safety.
The Food and Drug Administration (FDA) announced it is investigating at least 13 infant botulism cases across 10 U.S. states linked to powdered infant formula produced by ByHeart Inc. The affected states are Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, according to the Associated Press.
ByHeart has voluntarily recalled two specific lot codes of its Whole Nutrition Infant Formula: batch 206VABP/251261P2 and batch 206VABP/251131P2, both marked “Use by 01 Dec 2026.”
According to the FDA, the company’s formula accounts for an estimated 1% of U.S. infant formula sales, and the outbreak “does not create shortage concerns” for the broader market.
Infant botulism occurs when spores of the bacterium Clostridium botulinum germinate in an infant’s gut and release toxins, leading to symptoms such as poor feeding, loss of head control, difficulty swallowing, and decreased facial expression. These symptoms may appear several weeks after ingestion.
The CDC and state health departments are urging anyone whose infant consumed the recalled formula to monitor for symptoms and seek immediate medical attention if needed.
This incident has renewed scrutiny of safety and recall protocols for infant nutrition products. In July 2025, the FDA sent a letter to the industry calling for faster and more transparent recall communications for infant formula, baby food, and other products intended for children.
The recall also comes amid heightened food safety alerts for products aimed at infants and children. Recently, Sprout Organics baby food pouches were voluntarily recalled because of potentially elevated lead levels.
While no deaths have been reported in connection with the outbreak tied to ByHeart’s formula, insurers and regulators are expected to closely monitor the investigation’s findings on production processes, contamination pathways, and oversight of powdered infant formula manufacturing.
The FDA is continuing to collect and test leftover product from the recalled lots to determine the exact source of contamination.
For parents, the message remains clear: check any formula on hand, confirm lot codes, and if they match the recalled batches, dispose of or return the product to the place of purchase.
ByHeart advised customers to discard the affected products and said it will provide replacements.
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