Infant Botulism Formula Recall: Urgent Health Advisory for Parents

Image Source: Centers for Disease Control and Prevention | CDC (.gov)

The recent infant botulism formula recall has raised significant concerns among parents and caregivers across the United States. On November 8, 2025, the Centers for Disease Control and Prevention (CDC) along with public health officials and the FDA announced an investigation into a multi-state outbreak of infant botulism. This outbreak has been linked to two lots of ByHeart Whole Nutrition Infant Formula. The infant formula has been confirmed to pose a serious health risk for young children, potentially leading to serious illness.

Details of the Outbreak

As of now, there have been 13 reported cases of infant botulism, with all affected infants requiring hospitalization. Fortunately, no deaths have been reported. The outbreak spans 10 states and is under ongoing investigation. The CDC emphasizes the importance of immediate precautionary measures for parents who may have purchased this formula.

What is Infant Botulism?

Infant botulism occurs when spores of the bacterium Clostridium botulinum are ingested and produce neurotoxins in the intestines of infants. The symptoms often commence with constipation and can progress to difficulty feeding, altered crying patterns, reduced muscle tone, and in severe cases, flaccid paralysis.

Action Required for Parents

Parents are strongly advised to:

• Stop using any recalled lots of ByHeart Whole Nutrition Infant Formula.
• Discard the affected formula or return it to the retailer.
• Note the lot numbers: 206VABP/251261P2 and 206VABP/251131P2, both with “Use by 01 Dec 2026.”
• Maintain hygiene by thoroughly cleaning any surfaces or utensils that came into contact with the formula.
• Seek medical attention immediately if their infant shows symptoms such as poor feeding, lack of head control, difficulty swallowing, or decreased facial expression.

Symptoms of botulism may take weeks to manifest, hence vigilance is crucial during this period following the consumption of the recalled formula.

Response from ByHeart and FDA

The FDA has reported that ByHeart’s Whole Nutrition Infant Formula comprises only about 1% of total infant formula sales in the U.S. The organization reassures the public that this recall does not indicate an impending shortage of infant formula products on the market.

Role of Healthcare Providers

Healthcare professionals are encouraged to assess infants presenting with signs of botulism. Initial diagnoses should rely on clinical observations. Immediate consultation with the Infant Botulism Treatment and Prevention Program is recommended for any suspected cases. If diagnosis aligns with infant botulism, treatment with BabyBIG®, a botulism immune globulin, is advised to mitigate the severity of symptoms.

Staying Informed and Safe

As this situation continues to evolve, parents and caregivers should stay informed through reliable sources. The CDC will provide updates as they investigate this serious health concern. Awareness and prompt action can protect infants from the dangers of botulism.

What You Can Do

Parents are also encouraged to educate themselves on the symptoms of infant botulism and to practice safe feeding practices for their children:

• Always inspect infant formula products for recalls before use.
• Consult healthcare providers if unsure about any infant feeding practices.
• Promote cleanliness in feeding areas to avoid contamination.

Frequently Asked Questions

What should I do if my infant shows symptoms of botulism?

Seek immediate medical care. Early treatment is essential for better outcomes in suspected cases.

How can I find out if my formula is recalled?

Check the CDC and FDA announcements regarding recalls and utilize lot numbers on the packaging.

Is infant botulism common?

Infant botulism is rare, but it can be very serious. Prompt recognition and treatment are crucial.

Are all infant formulas affected by this recall?

No, the recall is specific to certain lots of ByHeart Whole Nutrition Infant Formula. Always confirm with health officials.

How can I safely feed my baby after this incident?

Make sure to use non-recalled formulas and always check for updates on product safety from trustworthy sources.