Powdered Formula Recall Over Botulism Risk Ends, What Parents Need To Know
A serious infant botulism outbreak that started in November 2025, tied to powdered infant formula has only recently concluded.
The outbreak was responsible for 48 cases across 17 states. Fortunately no deaths occurred, but all 48 cases required hospitalization. Highlighting the seriousness of botulism.
From the 48 cases, 28 were confirmed related to the powdered infant formula recall. The other 20 were probable but unconfirmed. The CDC also highlighted that three earlier suspected cases were ultimately excluded from the numbers.
The final case of reported botulism was in December 2025. However the case was only closed February 27, 2026, by the CDC and FDA.
Despite the case being closed, work continues on how Clostridium botulinum got into ByHeart powdered formula.
For context, the California Department of Public Health (CDPH) stated that ByHeart represents less than 1 percent of infant formula sales in the United States.
How the recall escalated
On November 8, 2025, ByHeart announced a voluntary recall of two batches after FDA notification of a broader investigation, and its notice described the move as being taken “out of an abundance of caution.”
The company listed the two affected batch codes and told families to stop using them immediately.
The FDA’s investigation page shows how quickly the case count climbed:
- As of November 10, the FDA reported 15 infants in 12 states with suspected or confirmed infant botulism and confirmed exposure to ByHeart formula, all hospitalized. A later FDA update reported 23 infants from 13 states.
- By November 19, the FDA and the CDC-backed recall update noted 31 infants with confirmed exposure from 15 states. ByHeart’s recall had expanded to all batches of ByHeart Whole Nutrition infant formula cans and Anywhere Pack sticks nationwide.
This outbreak renewed attention on a separate FDA-posted ByHeart recall back in December 2022. This included five batches for potential Cronobacter sakazakii cross-contamination.
Why officials treated this as an emergency
The CDPH said its Infant Botulism Treatment and Prevention Program first noticed an increase in infant botulism cases linked to ByHeart formula and alerted the CDC. This helped launch the multistate investigation.
The FDA later reported that some samples tested positive for Clostridium botulinum toxin Type A, including a closed ByHeart powdered formula sample that matched a clinical isolate by whole genome sequencing, plus matching findings in ingredient samples.
The FDA called this the first documented U.S. botulism outbreak attributed to contaminated infant formula.
What is Botulism?
Botulism is rare, but an incredibly serious illness. It is caused by a toxin that attacks the body’s nerves. It can cause breathing difficulty, muscle paralysis, and in some scenarios, death.
When it comes to botulism in infants, it can begin with constipation, poor feeding, a loss of head control, and trouble swallowing. If it is not treated, it can continue to flaccid paralysis.
In the warnings during the recall, the CDPH also listed symptoms including a weak or changed cry, low muscle tone, difficulty sucking, and respiratory issues.
The reason this case stayed open from November 2025 to February 2026 is because symptoms can take weeks to show up.
This story emphasizes the importance of monitoring recalls, especially if you have a young family.
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