ByHeart Formula Recall and Infant Botulism Outbreak: What Montana Parents Need to Know

As a Montana personal injury attorney who represents families harmed by defective products and corporate negligence, I’m deeply concerned about the recent nationwide recall of ByHeart infant formula linked to a multistate outbreak of infant botulism. Since August 2025, at least 23 infants across 13 states have been hospitalized after consuming this formula, and the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) continue to investigate this unprecedented outbreak. While no deaths have been reported, infant botulism is a serious, potentially fatal illness that requires immediate medical attention and can cause long-term complications for affected infants.

Understanding the ByHeart Formula Recall

On November 11, 2025, ByHeart, Inc. expanded its voluntary recall to include all ByHeart Whole Nutrition Infant Formula products nationwide, both cans and single-serve “Anywhere Pack” sticks. This came after the FDA notified the company on November 7, 2025, about an estimated 85 cases of infant botulism reported nationwide since August 2025, with 13 infants having consumed ByHeart formula.

The recall expansion was prompted by preliminary laboratory results from the California Department of Public Health suggesting the presence of Clostridium botulinum bacteria – the bacteria that produce botulinum toxin – in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with botulism. According to the FDA, this is the first time in history that infant formula has been linked to infant botulism cases.

Parents and caregivers must stop using any ByHeart formula immediately. This includes all lots and expiration dates, whether purchased in stores or online. ByHeart products represent approximately 1% of all infant formula sold in the United States, so this recall is not expected to create formula shortages.

What is Infant Botulism?

Infant botulism occurs when a baby swallows Clostridium botulinum spores that grow in the infant’s immature gut and produce botulinum neurotoxin. This toxin attacks the body’s nerves and causes progressive muscle weakness. According to the California Department of Public Health’s Infant Botulism Treatment and Prevention Program, the condition often starts with constipation but is usually first noticed through specific symptoms:

• Difficulty feeding (poor sucking and swallowing)
• Weak or altered cry
• Loss of head control
• Decreased facial expressions (drooping eyelids, less animated face)
• Generalized muscle weakness
• Difficulty breathing, which can progress to respiratory arrest

Critical timing: Symptoms of infant botulism can take as long as several weeks to develop after consuming contaminated formula. This means that even if your infant appears healthy today, you must remain vigilant for up to 30 days after their last exposure to ByHeart formula.

Infant botulism is treatable with BabyBIG® (Botulism Immune Globulin), an FDA-approved treatment consisting of antibodies that fight botulinum neurotoxins. All 23 infants in this outbreak were hospitalized and treated with BabyBIG®, and thankfully, no deaths have been reported. However, early diagnosis and treatment are critical to preventing serious complications.

The Scope of the Outbreak

As of November 14, 2025, the CDC and FDA have confirmed 23 cases of suspected or confirmed infant botulism linked to ByHeart formula across 13 states: Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. While Montana is not currently listed among the affected states, Montana families may have purchased ByHeart formula from online retailers or while traveling, making it crucial for all Montana parents to check their formula supplies.

The timeline is particularly concerning. Illnesses began in mid-August 2025 and continued through early November. According to the California Department of Public Health’s Infant Botulism Treatment and Prevention Program, 84 infants nationwide received BabyBIG® treatment for infant botulism between August 1 and November 10, 2025. Among those 84 cases:

• 43% (36 infants) had been exposed to powdered infant formula
• Of those with formula exposure, more than 40% (15 infants) consumed ByHeart formula

This data is striking: ByHeart represents only 1% of infant formula sales in the United States, yet accounted for more than 40% of formula-exposed botulism cases during this period. The FDA has stated that “ByHeart brand formula is disproportionately represented among sick infants in this outbreak,” and investigations have not identified any other infant formula brands that pose a risk to infants at this time.

What Montana Parents Should Do Immediately

If you have ByHeart formula in your home, the FDA and CDC recommend the following steps:

1. Stop using ByHeart formula immediately Do not feed any ByHeart Whole Nutrition Infant Formula to your infant, regardless of the lot number or expiration date.
2. Document and preserve the product
   • Take a photo or write down the lot number and expiration date found on the bottom of the container
   • Keep the container in a safe place and label it “DO NOT USE”
   • Do not throw it away yet – if your infant develops symptoms within 30 days, your state health department may want to collect it for testing
3. Clean all items that touched the formula Wash bottles, nipples, scoops, and any surfaces that may have contacted the formula using hot soapy water or a dishwasher.
4. Monitor your infant closely for 30 days Watch for any signs of infant botulism, including:
   • Constipation (often the first sign)
   • Poor feeding or difficulty swallowing
   • Weak cry or less vocal than usual
   • Loss of head control or “floppy” appearance
   • Decreased facial expressions
   • Weakness or lethargy
5. Seek immediate medical attention if symptoms develop If your infant shows any symptoms of botulism, do not wait – call 911 or go to the nearest emergency room immediately. Tell healthcare providers that your infant consumed ByHeart formula and may have infant botulism. Healthcare providers can call the Infant Botulism Treatment and Prevention Program at 510-231-7600 for consultation 24 hours a day, 7 days a week.
6. If no symptoms appear after 30 days You may dispose of the formula at that time.
   For non-emergency questions, parents can call the new Infant Botulism Hotline at 1-833-398-2022 (available 7 days a week, 7 AM – 11 PM Pacific time) or contact ByHeart’s customer support at 866-201-9069.

For non-emergency questions, parents can call the new Infant Botulism Hotline at 1-833-398-2022 (available 7 days a week, 7 AM – 11 PM Pacific time) or contact ByHeart’s customer support at 866-201-9069.

Why This Outbreak is Unprecedented

What makes this outbreak particularly concerning from both a public health and legal perspective is that it represents the first documented link between commercially manufactured infant formula and infant botulism cases in U.S. history. The FDA has stated: “There is no historical precedent of infant formula causing infant botulism.”

Infant botulism is typically associated with environmental sources like soil, dust, or contaminated honey (which is why honey should never be given to infants under 12 months). The bacterium Clostridium botulinum is rare in dairy products and processed foods, making this outbreak highly unusual.

As of the latest FDA update, no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, though the FDA notes that “detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.” The investigation is ongoing to determine the point of contamination and whether any additional products are affected.

Food safety experts have also raised concerns about ByHeart’s initial response to the outbreak. The company initially recalled only two lots on November 8, 2025, despite the FDA recommending a broader recall. It took three days for ByHeart to expand the recall to all products on November 11, 2025, after parents and caregivers reported that infants in the outbreak had consumed different lots not included in the initial recall. This delay potentially left additional infants at risk.

What This Means for Montana Families

While Montana has not been specifically identified as a state with confirmed cases in this outbreak, Montana parents should remain vigilant. ByHeart formula was sold online at ByHeart.com and in major retail stores nationwide, meaning Montana families could have purchased it locally or online. Additionally, families who traveled out of state may have used ByHeart formula while away from home.

As someone who represents Montana families harmed by defective products and corporate negligence, I know how product liability cases can have far-reaching effects on families. Infant botulism, even with treatment, can result in extended hospitalization – all 23 infants in this outbreak were hospitalized and required intensive medical intervention. The medical bills, lost wages from parents taking time off work, and emotional trauma of watching your infant struggle with a preventable illness can be devastating.

Beyond the immediate health risks, this outbreak raises important questions about product safety oversight and corporate accountability. Montana families who rely on commercially produced infant formula trust that these products meet the highest safety standards. When a company puts a product on the market, they have a responsibility to ensure it’s safe for its intended use, especially when that product is the sole source of nutrition for vulnerable infants.

The fact that ByHeart formula was disproportionately represented in this outbreak (accounting for over 40% of formula-exposed cases while representing just 1% of the market) suggests a potential systemic issue with this particular product. The ongoing FDA investigation will hopefully provide answers about how contamination occurred and whether the company took adequate steps to prevent it.

How Bliven Law Firm Can Help

If your infant consumed ByHeart formula and developed symptoms of botulism, or if you have concerns about potential long-term health effects from exposure to contaminated formula, you may have legal options. Product liability law holds manufacturers accountable when defective or contaminated products cause harm to consumers.

With experience in product liability and food safety cases, Bliven Law Firm, P.C. understands the unique challenges families face when seeking justice against large corporations. These cases often involve complex medical evidence, manufacturing records, and regulatory compliance issues. You need an attorney who will thoroughly investigate what happened, hold the responsible parties accountable, and fight for the full compensation your family deserves.

Potential damages in a product liability case involving infant botulism may include:

• Medical expenses (hospitalization, treatment, follow-up care)
• Future medical costs if long-term complications develop
• Lost wages for parents who missed work to care for their child
• Pain and suffering experienced by the infant
• Emotional distress for the entire family

Time is of the essence. Montana has specific statutes of limitations for product liability claims, and evidence needs to be preserved while the investigation is still ongoing. If you suspect your infant was harmed by ByHeart formula, don’t wait to seek legal advice.

Contact Bliven Law Firm today or fill out our online contact form to schedule a free consultation. As a Montana personal injury attorney dedicated to protecting families, I’m here to help you understand your rights, investigate your case thoroughly, and pursue the compensation and accountability your family deserves.

Kalispell Office

704 South Main Street
Kalispell, MT 59901

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202 North Main Street, Suite 1
Boardman, OR 97818

This blog post is for informational purposes only and does not constitute medical or legal advice. If your infant is experiencing symptoms, seek immediate medical attention by calling 911 or visiting the nearest emergency room.