December 16, 2025

ByHeart Infant Botulism Outbreak Has Sickened 51 Babies

The ByHeart infant botulism outbreak has now sickened 51 babies in 19 states, according to the CDC. All of the patients have been hospitalized. That is an increase of 12 new cases, 12 new hospitalizations, and one new state since the last update was issued a week ago. The new state is Ohio. The case count by state is: Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Maine (1), Michigan (1) Minnesota (3), North Carolina (2), New Jersey (1), Ohio (1), Oregon (4), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). The infants range in age from 16 to 264 days. Illness onset dates range from December 24, 2023 to December 1, 2025. All of the infants were hospitalized and treated with BabyBIG®, the … [Read more...]

ByHeart Formula Botulism Outbreak Sickens Two More Infants

The ByHeart formula botulism outbreak has sickened two more infants, bringing the total of sick babies to 39, according to the CDC. That is an increase from 37 sick since the last update was issued on November 26, 2025. And one more state is included: Virginia. The case count by state is: Arizona (3), California (5), Idaho (1), Illinois (2), Kentucky (1), Massachusetts (2), Maine (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (4), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). For 38 infants whose age was made available to public health officials, they range in age from 16 to 264 days. Illness onset dates range from August 9 to November 19, 2025 for 38 of these infants. All of the infants were hospitalized … [Read more...]

ByHeart Formula Botulism Outbreak Case Count Up to 37 Infants

The ByHeart formula botulism outbreak case count has now sickened 37 infants in 17 states, according to the Centers for Disease Control and Prevention (CDC). That's an increase of six new patients, six new hospitalizations, and two new states since the last update was issued on November 20, 2025. The new states are Massachusetts and Wisconsin. The case count by state is: Arizona (3), California (5), Idaho (1), Illinois (2), Kentucky (1), Massachusetts (1), Maine (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (8), Washington (2), and Wisconsin (1). For 35 infants whose age was made available to public health officials, they range in age from 16 to 264 days. Illness onset dates range from August 9 to November … [Read more...]

Recalled ByHeart Infant Formula Still Being Sold at Some Retailers

The FDA is claiming that recalled ByHeart infant formula is still being sold at some major retail stores. No recalled food item should ever be available for consumers to purchase. This product is linked to an infant botulism outbreak that has sickened at least 31 babies in 15 states. Reports have come in that the recalled formula is still on the shelves in multiple states, including Walmart, Target, and Kroger stores, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw's, and Star Market. All of ByHeart infant formula products have been recalled. The case count by state is: Arizona (3), California (4), Idaho (1), Illinois (2), Kentucky (1), Maine (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), … [Read more...]

Rep. Rosa DeLauro Demands ByHeart Inspection Records

Rep. Rosa DeLauro (D-CT) is demanding to see the ByHeart inspection records after the outbreak of infant botulism linked to that company's products has sickened at least 23 infants in 13 states. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health. The case count by state is: Arizona (3), California (3), Illinois (2), Kentucky (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (2), Pennsylvania (1), Rhode Island (1), Texas (3), and Washington (1). For 22 infants whose age is available, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 11, 2025. All of ByHeart's products have been recalled. Rep. DeLauro said in … [Read more...]

ByHeart Infant Botulism Outbreak Case Count Surges to 23

The ByHeart infant botulism outbreak case count has surged to 23 babies sick, according to the CDC, an increase of eight more illnesses since the last update was issued three days ago. One more state, Michigan, has been added to the investigation. The case count by state is: Arizona (3), California (3), Illinois (2), Kentucky (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (2), Pennsylvania (1), Rhode Island (1), Texas (3), and Washington (1). For 22 infants whose age is available, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 11, 2025. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health. Infant … [Read more...]

FDA On ByHeart Whole Nutrition Formula Botulism Outbreak

The FDA weighs in on the ByHeart Whole Nutrition Formula botulism outbreak, stating that, "Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country." The case count by state is: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), North Carolina (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). For 14 infants whose age is available, they range in age from 16 to 157 days. Illness onset dates range from August 9 to November 10, 2025. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California … [Read more...]

Minnesota Infant Sickened in ByHeart Formula Botulism Outbreak

A Minnesota infant is sickened in the ByHeart infant formula botulism outbreak, according to the Minnesota Department of Health (MDH). That infant got sick in August 2025. All of ByHeart's formula has been recalled after testing conducted in California found the possible presence of the Clostridium botulinum bacteria in an opened can of that product from the home of a sick infant. In all, there are now 15 infants who are ill after being fed ByHeart Whole Nutrition Infant Formula. The case count by state is: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), North Carolina (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). For 14 infants whose age was reported to public health officials, they range in age from 16 … [Read more...]

ByHeart Infant Formula Botulism Outbreak Sickens 15 Babies

The ByHeart Infant Formula botulism outbreak has now sickened 15 babies in 12 states, according to the Centers for Disease Control and Prevention (CDC). That is an increase of two more patients in two more states since the last update was issued three days ago. The new states are Kentucky and New Jersey. The case count by state is: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), North Carolina (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). For 14 infants whose age is available, they range in age from 16 to 157 days. Illness onset dates range from August 9 to November 10, 2025. All of the infants were hospitalized and treated with BabyBIG®. No deaths have been reported. According to information from the … [Read more...]

All ByHeart Infant Formula Is Recalled in Infant Botulism Outbreak

All ByHeart Infant Formula is recalled in relation to the infant botulism outbreak that has now sickened at least 15 babies nationwide. The original recall of two lots of the formula was expanded when the FDA learned that some sick infants had been fed other lots of that product. The California Department of Public Health conducted tests on an opened can of ByHeart Whole Nutrition Infant formula that was fed to and infant who contracted a botulism infection, and preliminary tests suggest the product contained Clostridium botulinum bacteria. The company maintains that no unopened can of their product has tested positive. The FDA is waiting for confirmed results of its testing, but in the meantime ByHeart is recalling all product from the market, and is testing every batch of … [Read more...]

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