Federal health officials are investigating a multistate outbreak of infant botulism tied to a powdered baby-formula brand, leading to the recall of two specific lots of product.
According to the Centers for Disease Control and Prevention (CDC), 13 infants — all of whom consumed the formula in question — have been hospitalized across 10 U.S. states. No deaths have been reported so far. The formula implicated is produced by ByHeart Inc., and the recalled lots are labeled 206VABP/251261P2 and 206VABP/251131P2, both with a “Use by” date of December 1 2026.
Infant botulism is caused when spores from the bacterium Clostridium botulinum are ingested, proliferate in an infant’s large intestine, and produce nerve-paralyzing toxin. Because infants’ digestive systems are immature, they are uniquely vulnerable to this rare but serious condition. Symptoms often begin subtly, with constipation and poor sucking, then progress to weak muscle tone, loss of head control, difficulty swallowing, decreased facial expression, and — in advanced cases — breathing difficulties.
The outbreak is notable because historical precedent for powdered infant formula leading to confirmed botulism is virtually nonexistent — a fact underscored by the CDC and public-health authorities. The implicated formula brand reportedly accounts for about 1 % of the U.S. infant-formula market, meaning that while the recall is serious, it does not currently pose a broad supply-shortage risk.
Parents or caregivers who have purchased ByHeart Whole Nutrition Infant Formula should immediately check the lot number and stop use if it matches one of the recalled codes. Surfaces and utensils that may have contacted the product should be thoroughly cleaned with hot soapy water or in a dishwasher. Moreover, if an infant has consumed the formula and shows any of the symptoms listed above, medical attention should be sought without delay. Symptoms can take several weeks to develop, so vigilance is required even if no immediate signs appear.
The food-safety investigation is ongoing. The Food and Drug Administration (FDA) is working with state health agencies and the manufacturer to determine the contamination source, to test unused product samples, and to assess whether other formulas or lots might be affected.
