What is BabyBIG? Treatment of choice for Infant Botulism

Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.

The Outbreak

As of November 8, 2025, 13 infants with suspected or confirmed infant botulism have been reported from 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 13 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. Infants ranged in age from 16 to 157 days. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 13 (100%) reported feeding ByHeart Whole Nutrition infant formula.

The Recall

ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by sick infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. FDA’s investigation is ongoing to determine the point of contamination and if any additional products are impacted.

Public Health Alert

Parents, do not use recalled infant formula. Throw it away or return it to where you bought it. If possible, record the lot number. Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.

Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:

• Poor feeding
• Loss of head control
• Difficulty swallowing
• Decreased facial expression
• Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula.

What businesses should do

• Do not sell or use recalled infant formula.
• Wash and sanitize items and surfaces that may have touched recalled formula.

What clinicians should do

• Initial diagnosis of infant botulism is based on clinical symptoms. Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing. If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
• If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
• Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7. Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.

What is BabyBIG®?

(Botulism Immune Globulin Intravenous (Human), or BIG-IV) is an FDA-approved orphan drug used to treat infant botulism caused by toxin types A and B in patients under one year of age. It consists of human-derived antibodies that bind to and neutralize the botulinum neurotoxin circulating in the bloodstream. 

Purpose: The primary purpose of BabyBIG® is to immediately stop the progression of toxemia (toxin in the bloodstream) in infants with botulism, which enables motor nerve regeneration to begin sooner. This treatment significantly shortens the length of hospital stays and reduces the need for mechanical ventilation compared to supportive care alone.

Mechanism: The active ingredient is purified immunoglobulin G (IgG) antibodies derived from the pooled plasma of adults who were immunized with a botulinum vaccine. These antibodies neutralize the specific botulinum neurotoxins (types A and B) that cause the illness in infants.

Administration: It is administered as a single intravenous infusion. Treatment should begin as soon as infant botulism is suspected based on clinical symptoms, without waiting for laboratory confirmation.

Availability: BabyBIG® is a public service orphan drug and is only available through the Infant Botulism Treatment and Prevention Program (IBTPP), which is run by the California Department of Public Health (CDPH). Physicians must contact the IBTPP for a clinical consultation to obtain the medication.

Side Effects: The most common side effect observed in clinical trials was a mild, transient skin rash. Other potential adverse reactions, typical of other intravenous immune globulin (IGIV) products, can occur but were not frequently observed in BabyBIG® specific trials.

Thanks to folks at CDC, FDA and state and local health authorities for working weekends.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/what-is-babybig-treatment-of-choice-for-infant-botulism/