--- title: "After 2 infant formula botulism outbreaks, families ask if warning signs were missed" date: 2026-08-26T10:22:00-07:00 author: Julie Dueck canonical_url: "https://marlerclark.com/news_events/after-2-infant-formula-botulism-outbreaks-families-ask-if-warning-signs-were-missed" section: News --- [All News](/news_events) / [Case News](https://marlerclark.com/news_events/case-news) / # After 2 infant formula botulism outbreaks, families ask if warning signs were missed **ABC 4 News | By Lisa Fletcher, Andrea Nejman and Nathan Aaron | August 21, 2026** [Foodborne illness](https://wjla.com/topic/Foodborne%20illness) outbreaks have repeatedly made headlines this summer. Dozens of families whose babies were sickened by contaminated [infant formula](https://wjla.com/topic/infant%20formula) say they fear their children — and the questions surrounding what happened to them — are being forgotten. Two infant [botulism](https://wjla.com/topic/botulism) outbreaks tied to powdered formula remain under investigation. Now, we’re examining what federal regulators knew about the risk, what happened after an early warning to the industry and whether existing safeguards are enough to prevent another outbreak. When Amy Mazziotti arrived at the pediatrician with her 5-month-old son, Hank, the baby was on the brink of a medical crisis. ![](https://s3-us-west-2.amazonaws.com/marlerclarkcom-publications-pdfs/19c84537-7317-4948-805e-fc0c4ee578ab-Screenshot20260820090720.webp)Baby Hank was rushed to the hospital after his body went limp. Doctors determined he had ingested the botulism toxin. Photo: Mazziotti Family“He just kind of flopped down and wasn't moving,” Mazziotti recalled. “And she \[the pediatrician\] just looked at me and she said, ‘Amy, you need to get him to the emergency room.’” Hank would undergo hours of tests and evaluations as his condition rapidly deteriorated. > I did a hundred percent think that there was a chance that Hank could die because he wasn't getting better and progressively getting worse and fast,” Mazziotti said. Doctors suspected infant botulism, a rare but potentially deadly illness caused when Clostridium botulinum spores grow in an infant’s intestine and produce a toxin that attacks the nervous system. Symptoms can include not eating, loss of head control and difficulty swallowing, and can progress to difficulty breathing and respiratory arrest. Mazziotti became convinced the source was Hank’s infant formula. ![](https://s3-us-west-2.amazonaws.com/marlerclarkcom-publications-pdfs/1e64a4b5-c352-415a-8e38-d3b1e8dc3539-Screenshot20260820090856.webp)Amy Mazziotti says she wants answers as to why her child got botulism after she bought infant formula she thought was safe for her baby. Photo: SBG> "Every time a doctor came in, I asked about the formula,” she said. “I just couldn't let it go. I almost felt like I was being gaslit because they were like, ‘No, there's no way. There's no way. Why are you even thinking that?’ Months later, ByHeart Whole Nutrition Infant formula was recalled nationwide, tied to cases of botulism. Ultimately, 48 babies in 17 states were identified in the outbreak. [The Centers for Disease Control and Prevention](https://wjla.com/topic/Centers%20for%20Disease%20Control%20and%20Prevention) declared it over on Feb. 26, 2026, though the FDA’s investigation into the root cause continued. [FDA](https://wjla.com/topic/fda) testing found C. botulinum in a powdered milk ingredient used by ByHeart, including samples from Dairy Farmers of America, which processed milk supplied by Organic West Milk. Whole genome sequencing linked two samples of the organic whole milk powder to a clinical sample from a sick infant and to contaminated infant formula. ![](https://s3-us-west-2.amazonaws.com/marlerclarkcom-publications-pdfs/6f4af786-8fe1-4503-a94b-612db1f48ac5-Screenshot20260820090749.webp)48 babies were sickened with botulism or suspected botulism after the first outbreak. Photo: SBGThe FDA has called the ByHeart outbreak the first U.S. botulism outbreak definitively tied to infant formula since infant botulism was first recognized. Within months, it was happening again. Four more babies, in California, Pennsylvania and Washington, developed confirmed infant botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula. All four were hospitalized. Nara recalled all of its infant formula sold in the U.S. The FDA says C. botulinum was detected in an opened can collected from the home of one of the sick infants, though the agency has not determined the ultimate source or route of contamination. > If I'm being told at the hospital that no, there's never been a case of this, no baby has ever gotten botulism, and then less than a year later there's two recalls on this, something's wrong,” Mazziotti said. The FDA had been aware of the potential botulism risk for years. In 2023, the agency warned formula makers that powdered infant formula had a historical association with pathogens including Clostridium botulinum and said those hazards should be considered when companies design and implement food-safety controls. FDA urged manufacturers to take “prompt action” to improve their safety processes and programs. “This was a risk just waiting to happen,” said Bill Marler, a nationally known food safety attorney who represents families whose babies were sickened. Marler argues that the consequences of these outbreaks did not end when the recalls ended. “Many of the media and the government officials have moved on and the industry is trying to move on, but some of these kids may have lifetime complications,” he said. He also questions how often policymakers hear directly from families who have lived through severe foodborne illness. > I can count on one hand how many times a government official has reached out to a parent or had a parent come and testify about what it was like to watch their child maybe gasp for breath, to be on a feeding tube,” Marler said. Rep. Rosa DeLauro, D-Conn., has been one of Congress’ most persistent advocates for stronger infant formula oversight. We asked if she’d support a congressional hearing to get answers about the outbreaks. “I would look into that certainly,” said DeLauro. I think it's very important to do that.” As a member of the minority party in the House, DeLauro cannot unilaterally call an official committee hearing. “I can't call a hearing in the minority because we're in the minority, but I can do briefings,” she said, adding, “We tried to do a briefing and the FDA was less than cooperative.” DeLauro has also introduced the bipartisan Infant Formula Safety Modernization Act of 2026. The bill would direct FDA to expand the list of pathogens infant formula manufacturers are required to test for and specifically require Clostridium botulinum to be included. It would also mandate standardized environmental monitoring at formula plants, require manufacturers to notify FDA of positive pathogen tests and require notification to Congress of certain positive tests and serious FDA inspection findings. Current federal regulations require finished infant formula testing for Cronobacter and Salmonella, but not C. botulinum. The bill was introduced in March and referred to the House Energy and Commerce Committee. It was among the measures considered during an April 29 legislative hearing before the committee’s Health Subcommittee. As of Aug. 14, official congressional records do not show that the bill has advanced to a committee markup or House vote. We asked Energy and Commerce Chairman Rep. Brett Guthrie, R-Ky., whether he would move the legislation forward. His office did not respond. For Mazziotti, the issue is far less complicated. > You should not have to think, ‘Is this formula I'm buying going to harm my baby?’” she said. Hank has recovered, but Mazziotti said her family still carries the trauma of the weeks he spent seriously ill. She worries that without stronger safeguards, another outbreak could follow. “Every story I see about it, it ends like, ‘There's been no death, so it's OK,’” Mazziotti said. “But just because they didn't die doesn't mean they're OK. Is that what it takes? A baby has to die for it to become important?” ![](https://s3-us-west-2.amazonaws.com/marlerclarkcom-publications-pdfs/4de8d097-5c00-48be-b7e1-883b2599be03-Screenshot20260820090832.webp)Amy Mazziotti says the botulism didn't just impact Hank. His older siblings were traumatized by what happened to their infant brother. Photo: Mazziotti FamilyByHeart did not respond to our questions. Nara said it's working with public health agencies and follows the highest standards for safety. **To find contact information for your local lawmaker to weigh in on the bill currently in Congress, click [here](https://www.usa.gov/elected-officials).** ### Other Botulism Lawsuits [Infant Formula and Botulism Again - Three Sick](https://marlerclark.com/the-ten-largest-foodborne-illness-outbreaks-in-the-u-s-since-1993-and-marler-clarks-role-in-them) [By Heart Infant Formula tied to Botulism Outbreak spikes to 51](https://marlerclark.com/by-heart-infant-formula-tied-to-botulism-outbreak) [Botulism Outbreak at Valley Oak Food and Fuel](https://marlerclark.com/botulism-outbreak-at-valley-oak-food-and-fuel) [Marler Clark Files Two Botulism Lawsuits](https://marlerclark.com/marler-clark-files-two-botulism-lawsuits) ### Lawsuit updates about foodborne illnesses [Reactive Arthritis Lawsuit Updates](/news_events/case-news?illness=reactive-arthritis&year=all) [E. coli Lawsuit 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The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more. [ Get a free consultation ](https://marlerclark.com/contact) ##### Related Resources ###### [What is Botulism?](https://marlerclark.com/foodborne-illnesses/botulism/what-is-botulism) Botulism is a life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium—Clostridium botulinum. Botulism is a rare disease and only affects a few hundred persons each... ###### [Epidemiology and Microbiology of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/epidemiology-and-microbiology-of-botulism) C. botulinum bacteria and spores are widely distributed in nature because they are indigenous to soils and waters. They occur in both cultivated and forest soils, bottom sediment of streams... ###### [Symptoms of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/symptoms-of-botulism) After their ingestion, botulinum neurotoxins are absorbed primarily in the duodenum and jejunum, pass into the bloodstream, and travel to synapses in the nervous system. There, the neurotoxins cause flaccid... ###### [Detection and Treatment of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/detection-and-treatment-of-botulism) Although botulism can be diagnosed based on clinical symptoms, distinguishing it from other diseases is often difficult, especially in the absence of other known persons affected by the condition. Common... ###### [Botulism Outcomes and Long-Term and Permanent Injury](https://marlerclark.com/foodborne-illnesses/botulism/botulism-outcomes-and-long-term-and-permanent-injury) In the past 50 years, mortality from botulism has fallen dramatically (from about 50% to 8%) because of advances in supportive care, which is the mainstay of treatment. The respiratory... ##### Outbreak Database #### Looking for a comprehensive list of outbreaks? The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more. [ View Outbreak Database ](https://outbreakdatabase.com)