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...]
Byheart Infant Formula Botulism Outbreak Has Sickened 31
The Byheart Infant Formula botulism outbreak has sickened 31 babies as of November 19, 2025, according to the CDC, an increase of eight more patients since the last update was issued on November 14, 2025. All eight infants have been hospitalized, and two more states are added to the case count. The new states are Idaho and Maine. 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), Texas (6), and Washington (2). For 23 infants whose age was made available to public health officials, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 13, 2025 for 27 of these infants. All of the … [Read more...]
California Sets Up ByHeart Infant Formula Botulism Hotline
California has set up a ByHeart Infant Formula botulism hotline to answer questions and concerns of parents and caregivers about the outbreak that has sickened 23 infants in 13 states. This hotline was created since the Infant Botulism and Prevention Program (IBTPP) has been receiving a very high volume of emails and calls. The hotline number is 1-833-398-2022. It is open seven days a week from 7:00 am to 11:00 pm Pacific Time. But it's important that if your child is showing signs of infant botulism, you should contact your healthcare provider. Seek medical care immediately if you are very concerned. 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), … [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...]
FDA Warned ByHeart About Insanitary Conditions Two Years Ago
The FDA warned ByHeart about insanitary conditions in their facility more than two years ago during the worry about Cronobacter in infant formula. A warning letter was sent on August 30, 2023. The letter states, "During our inspection at the (b)(4) facility, FDA investigators found significant violations of Title 21, Code of Federal Regulations, Part 106 (21 C.F.R. Part 106), Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications (“the Infant Formula Rule”)." This information is interesting because powdered ByHeart Whole Nutrition Infant Formula is linked to a botulism outbreak that has sickened 15 infants in 12 states. The California Department of Health conducted testing on … [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...]
