Botulism and Powdered Formula

What is botulism?

Botulism is a rare but serious illness caused by a toxin produced by the bacterium Clostridium botulinum. This toxin is can lead to severe paralysis and potentially be life-threatening if not treated promptly. In infants, botulism is often linked to consuming honey or powdered formula that contains spores of the bacteria. The botulism spores germinate in the infant's immature digestive system, producing botulinum toxin.

Symptoms of botulism in infants include:

• constipation

• weak or altered cry

• poor feeding- difficulty sucking and swallowing

• generalized muscle weakness- low muscle tone

• drooping eyelid (ptosis)

• sluggish pupils

• respiratory difficulty

Incidence

There have been an estimated 83 cases of infant botulism in the USA since August 2025. Of these babies, at least 13 infants across 10 states received the By Heart brand of powdered formula at some point. While there is no direct link or specific evidence that ByHeart formula contained the botulism spores, they have recalled certain lots out of an abundance of caution.

Treatment

Prompt medical intervention, including antitoxins and supportive care, is crucial to avoid respiratory failure and to assist with recovery.

Why is powdered formula to blame?

Ready-to-feed formula is heat-treated during manufacturing to ensure it is sterile. In contrast, powdered formulas cannot be sterilized and may contain bacterial spores, including those that cause botulism. Botulism spores are also found in soil, certain vegetables, and dust, so preparing formula in unsanitary conditions or using unclean bottles, teats, or utensils can introduce contamination. Furthermore, each time a can of powdered formula is opened, the risk of contamination increases.

What you can do

• If you have not yet given birth, consider exclusive breastfeeding to eliminate the possibility of formula recalls affecting you.

• Be sure to prepare powdered formula in as clean an environment as possible.

• Sign up for recalls and safety alerts on the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts