Live Update
A major recall has been issued for certain batches of By Heart Whole Nutrition Infant Formula after health officials linked the product to multiple cases of infant botulism across 10 U.S. states, the Centers for Disease Control and Prevention (CDC) confirmed Saturday.
According to the CDC, 13 infants have been hospitalized with confirmed cases of the rare but serious illness, which can cause muscle weakness, difficulty feeding, and, in severe cases, paralysis. So far, no deaths have been reported.
The outbreak has affected families in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The recall covers two specific formula lots:
Lot 206 VABP/251261P2 (Use by Dec. 1, 2026)
Lot 206 VABP/251131P2 (Use by Dec. 1, 2026)
The affected products were sold nationwide both online and in major retail stores.
The Food and Drug Administration (FDA) is investigating how the contamination occurred, while By Heart has voluntarily pulled the affected lots from the market. “We are working closely with the FDA and CDC to ensure full transparency and consumer safety,” the company said in a statement.
What Parents Should Do
Officials urge parents and caregivers to stop using formula from the recalled lots immediately. Anyone who purchased the product should dispose of it or return it to the store for a refund. Surfaces, bottles, and utensils that came into contact with the formula should be thoroughly washed and sanitized.
Parents who suspect their infant may have consumed the recalled formula should watch for early signs of botulism, including:
Constipation
Poor feeding or weak sucking
Loss of head control
Weak or floppy muscles
Trouble swallowing or breathing
Anyone noticing these symptoms should seek medical attention immediately.
Broader Concerns
This recall comes as the U.S. continues to rebuild consumer confidence in the infant formula market following previous shortages and safety scares. Although By Heart makes up a small share of the overall market, the incident raises renewed questions about quality control and safety oversight in formula manufacturing.
Regulators have pledged to strengthen production and inspection protocols to prevent similar contamination in the future.