Nov 2025 Infant Botulism Outbreak: Formula Recall Alert
Federal health officials are investigating a multistate outbreak of infant botulism that has affected 13 babies across 10 states. The FDA and CDC have linked the cases to ByHeart Whole Nutrition Infant Formula, prompting the company to voluntarily recall two specific lots of their product on November 8, 2025. FDACDC All 13 infants were hospitalized and treated with BabyBIG, with illnesses starting from mid-August through November 2025, but thankfully no deaths have been reported. CDC This urgent health alert has left many parents concerned about formula safety and wondering what steps they should take to protect their babies.
#InfantBotulism
Understanding the November 2025 Formula Recall
ByHeart Inc. agreed to initiate a recall of two lots of ByHeart Whole Nutrition Infant Formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) after the California Department of Public Health reported an increase in botulism type A infections among infants consuming this powdered formula from August 2025 to November 2025. FDA
Which States Are Affected?
Cases have been reported in 10 states: Arizona, California (2 cases), Illinois (2 cases), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2 cases), and Washington. FDACDC The affected infants ranged in age from 16 to 157 days old. CDC
Quick facts about the outbreak:
- Total cases: 13 confirmed or suspected infant botulism cases - Hospitalizations: All 13 infants were hospitalized - Deaths: Zero fatalities reported - Timeline: August 2025 through November 2025 - Product reach: Available online and at major retailers nationwide - Market share: Less than 1% of all infant formula sold in the U.S.
What Is Infant Botulism and Why Is It Dangerous?
Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby's large intestine and produces toxin in it. This toxin attacks the body's nerves and can cause difficulty breathing, muscle paralysis, and in severe cases, even death. CDC
Unlike botulism in older children and adults, infant botulism can come on slowly and get gradually worse over time. Fortunately, it is still very treatable when caught early. Cleveland Clinic
Why Babies Are Vulnerable
Infantile botulism occurs exclusively in children younger than 12 months due to their immature immune system, reduced gastric acidity, and limited bacterial flora. Older children have sufficient gastric acidity to prevent C. botulinum spore germination. NCBI
Warning Signs Every Parent Must Know
Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. CDC
Critical Symptoms to Watch For
Parents should watch for these warning signs: KidsHealth
Early symptoms:
- Constipation (often the first sign parents notice) - Poor feeding or weak sucking - Weak or altered cry - Lethargy and decreased movement - Weak facial muscles making the face look "flat" - Decreased facial expressions - Loss of head control - Drooping eyelids (ptosis) - Weak muscles in arms, legs, and neck (floppiness) - Difficulty swallowing with excessive drooling - Breathing problems
If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care. Botulism can be fatal, and you should take action right away. FDA
#InfantBotulism
Actionable Steps for Parents Right Now
If You Have the Recalled Formula
Step 1: Check Your Formula Immediately
Look for these lot codes on the bottom of your formula cans: 206VABP/251261P2 and 206VABP/251131P2. FDA
Step 2: Stop Using It Immediately
Parents and caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child has consumed the formula and you still have it in your home, record the information on the bottom of the package before throwing it away. FDA
Step 3: Clean Thoroughly
Use a dishwasher or hot, soapy water to clean items and surfaces that touched the formula. WHYY
Step 4: Watch for Symptoms
The incubation period ranges from 10 to 30 days, with symptoms potentially taking several weeks to develop following formula ingestion. NCBI Monitor your baby closely during this period.
Step 5: Seek Medical Care If Needed
If you are a physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7. FDA
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How Is Infant Botulism Treated?
Babies with infant botulism need care in a hospital, usually in the intensive care unit (ICU). Doctors treat infant botulism with an antitoxin called botulism immune globulin intravenous (BIGIV), giving this to babies as soon as possible if they suspect botulism. KidsHealth
Recovery and Prognosis
Babies with botulism who receive BIGIV early recover sooner and spend less time in the hospital than babies who don't. With early diagnosis and proper medical care, a baby should fully recover from the illness. KidsHealth
Treatment may include:
- BabyBIG (botulism immune globulin) antitoxin - Intensive care monitoring - Breathing support with ventilator if needed - IV fluids or tube feeding for nutrition - Physical and occupational therapy during recovery
What ByHeart and Health Officials Are Saying
According to ByHeart's statement, the FDA notified them on November 7, 2025, of an estimated 83 cases of infant botulism reported nationwide since August 2025, with 13 of those infants receiving ByHeart formula at some point. FDA
The company stated: "While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants." FDA
Testing Results Pending
Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but are expected in the coming weeks. FDA However, California Department of Public Health tested a can of powdered infant formula that was fed to an infant with infant botulism, and preliminary results suggest the presence of the bacteria that produce botulinum toxin. NBC News
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Preventing Infant Botulism: Essential Safety Tips
While not all cases are preventable, parents can take these precautions:
1. Never Give Honey to Infants Under 1 Year Never give honey or any processed foods that contain honey (like honey graham crackers) to babies younger than 1 year old. These bacteria are harmless to older kids and adults. KidsHealth
2. Practice Safe Food Preparation
- Cook vegetables thoroughly when making homemade baby food - Follow proper canning procedures if preparing homemade foods - Keep preparation surfaces clean - Keep babies away from agricultural or construction sites - Maintain clean living environments - Reduce exposure to soil and dust - Check expiration dates regularly - Store formula properly according to instructions - Report any unusual appearance, smell, or texture - Sign up for FDA recall alerts - Follow CDC guidelines for infant feeding - Maintain regular pediatrician appointments
Will This Cause a Formula Shortage?
The FDA reports that ByHeart Whole Nutrition Infant Formula makes up an estimated 1% of all infant formula sales in the United States, and this outbreak does not create shortage concerns of infant formula for parents and caregivers. CDC
Parents can safely switch to other trusted formula brands without worrying about availability issues.
#InfantBotulism
What's Next in the Investigation?
The FDA's investigation is ongoing to determine the point of contamination and if any additional products are impacted. The advisory will be updated as information becomes available. FDA
ByHeart uses organic, grass-fed whole milk and operates facilities in Iowa, Pennsylvania, and Oregon that produce formula sold at nearly 12,000 retailers. NBC News Investigators are working to identify exactly where and how contamination may have occurred.
Resources for Concerned Parents
Emergency contacts:
- Infant Botulism Consultation: 510-231-7600 (available 24/7) - ByHeart Customer Service: [email protected] - FDA Consumer Complaints: Visit FDA.gov or call your local FDA Consumer Complaint Coordinator - Complete an electronic Voluntary MedWatch form online at FDA.gov - Call your pediatrician immediately if symptoms develop - Report to your state health department
Conclusion: Stay Vigilant and Informed
The November 2025 infant botulism outbreak linked to ByHeart formula serves as a critical reminder of the importance of food safety vigilance. While this situation is concerning, the swift response from health officials and the company's voluntary recall demonstrate the systems in place to protect our most vulnerable population.
Key takeaways for parents:
✅ Check your formula cans immediately for recalled lot numbers ✅ Discard affected products and clean all surfaces thoroughly ✅ Monitor your baby for warning signs over the next several weeks ✅ Seek immediate medical attention if symptoms develop ✅ Stay updated on the FDA investigation results
Treatment with BabyBIG is recommended for all suspected cases of infant botulism, and with early intervention, babies make full recoveries. CDC The most important step you can take is staying informed and acting quickly if you have the recalled formula or notice any concerning symptoms in your baby.
Remember: You're not alone in this. Healthcare providers, the FDA, CDC, and state health departments are working around the clock to ensure infant safety. When in doubt, always consult your pediatrician.
Stay safe, stay informed, and trust your parental instincts!