ByHeart has recalled all of its infant formula products nationwide after federal health officials linked the products to a widespread botulism outbreak that has sickened at least 31 babies across 15 states.
The company initially pulled specific batches after the FDA notified them on November 7 that 13 infants who had consumed ByHeart formula were among approximately 83-85 reported cases of infant botulism since August 2025. Within days, the recall expanded dramatically.
“Within 24 hours, we voluntarily recalled the initially identified batches. On Nov 11, 2025, we expanded the recall to include all batches nationwide,” ByHeart stated in a company update from its founders.
How serious is the contamination?
Very. Laboratory testing revealed evidence of Clostridium botulinum bacteria in multiple formula samples, prompting the company to take the extraordinary step of recalling everything. The recall covers all batches of ByHeart’s Whole Nutrition Infant Formula cans and their Anywhere Packâ„¢ sticks.
The CDC has confirmed that at least 31 infants across 15 states have fallen ill in the outbreak. Health officials are concerned the number could rise as more cases are investigated.
Botulism is a rare but serious illness caused by toxins produced by the Clostridium botulinum bacteria. In infants, it can cause difficulty feeding, muscle weakness, constipation, and in severe cases, breathing problems requiring hospitalization.
The company’s decision to recall all products came after it couldn’t guarantee the safety of any batch. “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company acknowledged in its statement.
Parents who have purchased ByHeart formula are being advised to stop using it immediately and contact their healthcare providers if their infants show any symptoms of illness.
This recall represents one of the largest infant formula safety actions since the Abbott Nutrition shutdown in 2022, which triggered nationwide shortages. That said, ByHeart is a smaller player in the formula market, so experts don’t anticipate the same level of supply disruption.
For affected families, the immediate concern isn’t store shelves but what might already be in their pantries. The FDA has promised to continue its investigation into how the contamination occurred and whether additional oversight of infant formula manufacturing is needed to prevent similar outbreaks in the future.
