The U.S. Food and Drug Administration recently declared the American infant formula supply to be “safe,” citing what it described as “the largest and most rigorous” contaminant testing in the history of the country. This announcement has left many parents frustrated and searching for answers, especially those whose children were hospitalized due to botulism linked to formula, WJLA reports. The disconnect between the agency’s public messaging and the reality on the ground is difficult for families like the Connollys to process. Katie Connolly experienced this crisis firsthand in 2024 when her 8-month-old daughter, MJ, suddenly lost the ability to move. The situation escalated rapidly as the infant was rushed to the emergency room, where she required an IV, a catheter, and a feeding tube. Katie described the experience as horrifying, noting that her daughter was so weak that she could not even cry. Doctors eventually diagnosed the child with botulism, and Katie spent a night watching over her daughter, keeping a hand on her chest to ensure she was still breathing. MJ eventually recovered after receiving a lifesaving anti-toxin, but the ordeal left a lasting impact on her family Katie now keeps a vial of that antitoxin as a reminder of the event. She remains skeptical of the agency’s assurances regarding the safety of products on store shelves. “I don’t have confidence that if I were to pull a bottle or a can of formula off of the shelf and feed it to my son when he’s born, that I would feel safe,” she said. FDA says infant formula 'safe.' Parents whose babies got botulism want answers: https://t.co/EE8iq99BLj pic.twitter.com/l2csJZbT5H— Local 12/WKRC-TV (@Local12) September 16, 2026 The FDA has been aware of the risks associated with botulism in infant formula for a long time. Records indicate the agency issued a warning to the industry in 2023 regarding potential contamination, revealing it had already conducted investigations involving infants who had consumed powdered formula. An examination of an FDA database shows reports of botulism potentially linked to these products going back more than 20 years. Attorney Bill Marler, who represents several affected families, believes these outbreaks were preventable. “If you look at the history of botulism spores in infant formula, it doesn’t take somebody who was paying attention to realize that this was a risk just waiting to happen,” Marler said. Even as dozens of babies were hospitalized in an outbreak linked to ByHeart formula, the agency moved forward with its testing program. On November 20, 2025, officials from the FDA and the CDC spoke with ByHeart about the investigation. Only four days later, the agency collected samples from the company for its massive safety report. Crucially, the FDA did not test any of the samples in this study for pathogens. Sandra Eskin, the former head of Food Safety at the USDA, noted that important safety priorities were missed. “Why haven’t they prioritized sampling to focus on a number of other pathogens that we’re seeing?” Eskin asked. “That’s where FDA should prioritize its work. It’s an immediate risk. It has been a problem.” The situation remains volatile. Weeks after the FDA declared the supply safe, more cases surfaced involving a different company, Nara Organics, leading to another nationwide recall and the hospitalization of four more infants. The agency has not responded to inquiries regarding why pathogens were excluded from its report or why that decision was not reconsidered as more babies became ill. For parents like Katie Connolly, who says she has never heard from the agency, the official narrative feels disconnected from the truth. “How could they make that statement knowing what has happened?” she asked. “It wasn’t safe for our family.” The FDA states its investigation into the root cause is ongoing.