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Ishita Roy

Byheart Formula Recall Update: 2 More Infants Hospitalized, FDA Says

Health and Me had previously <a href="https://www.healthandme.com/health-news/byheart-baby-formula-recalled-as-10-us-states-report-13-cases-of-infant-botulism-after-use-article-153122772" data-type="tilCustomLink">reported </a> on the recall of <span>ByHeart</span> Baby Formula after 10 US states reported 13 cases of <span>infant botulism</span> after its use. Ever since the botulism outbreak, two more cases of infant botulism was reported, making the outbreak across 12 US states, as confirmed by the Food and Drug Administration (FDA), US's advisory. 

As of now, a total of 15 cases of infant botulism has been reported, confirmed the Centers for Disease Control and Prevention (CDC), US. 

FDA in its advisory said, "For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized."

Also Read: <a href="https://www.healthandme.com/health-wellness/diabetes-no-longer-a-disease-of-aging-four-things-youth-should-know-about-it-according-to-doctor-article-153132665" data-type="tilCustomLink" target="_blank">Diabetes No Longer A Disease Of Aging; Four Things Youth Should Know About It, According To Doctor</a>

From the information available, of the 14 infants, the age ranged from 16 days to just over 5 months, and half of them were females. The FDA confirmed that the infants who fell ill were all fed ByHeart Whole Nutrition powdered infant formula.

The multistate outbreak is now being investigated by FDA, CDC, and California Department of Public Health Infant Botulism Treatment and Prevention Program, and other state and local health authorities, the advisory stated. On Tuesday, ByHeart informed that the company is expanding its earlier recall in order to include all batches of the baby formula and the Anywhere Pack single-serve sticks nationwide. 

"The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority. This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve," said Mia Funt, the president and co-founder of the company.

Also Read: <a href="https://www.healthandme.com/health-wellness/amid-delhis-health-emergency-doctors-warn-that-exposure-to-toxic-poisonous-air-does-not-build-pollution-immunity-urge-to-mask-up-article-153132100" data-type="tilCustomLink" target="_blank">Exposure to Toxic, Poisonous Air Does Not Build Pollution Immunity, Doctors Warn!</a> 

Most common form of all botulism in babies, who are between 2 to 8 months old. It happens when the bacteria spores grow in a baby’s intestines and produce the toxin. Honey and contaminated soil can be sources of infant botulism. Adults can also get this type, though it’s rare.

<h2>What Are The Symptoms Of Botulism In Infants?</h2>

<ul><li>Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing</li><li>If untreated, infants with infant botulism experience a progressive flaccid paralysis that can lead to breathing difficulties and required weeks of hospitalization.</li></ul>

<h2>States Hit By Infant Botulism Outbreak:</h2>

As per the FDA advisory, here is the list of states affected by infant botulism:

<ol><li>Arizona</li><li>California</li><li>Illinois</li><li>Kentucky</li><li>Minnesota</li><li>North Carolina</li><li>New Jersey</li><li>Oregon</li><li>Pennsylvania</li><li>Rhode Island</li><li>Texas</li><li>Washington</li></ol>

The company ByHeart Inc's two lots of Whole Nutrition Infant Formula has been recalled, the lots are:

As per the FDA advisory, parents and caregivers should stop using any ByHeart infant formula products immediately. Furthermore, the advisory notes:

<ul><li>If your child consumed <span rel="noindex">ByHeart formula</span> and is experiencing symptoms (see below) seek immediate medical attention.</li><li>If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.</li><li>If you still have the formula in your home, you should:</li></ul>                                  •take a photo or record the information on the bottom of the package.

                                  •keep the container in a safe spot and be sure to label that product as DO NOT USE.

                                  •If your child develops symptoms your state health department might want to collect your                                                formula container for testing. If your child does not develop symptoms after 30 days, throw                                            your containers out.

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Health and Me had previously reported  on the recall of ByHeart Baby Formula after 10 US states reported 13 cases of infant botulism after its use. Ever since the botulism outbreak, two more cases of infant botulism was reported, making the outbreak across 12 US states, as confirmed by the Food and Drug Administration (FDA), US's advisory. As of now, a total of 15 cases of infant botulism has been reported, confirmed the Centers for Disease Control and Prevention (CDC), US. FDA in its advisory said, "For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized."Also Read: Diabetes No Longer A Disease Of Aging; Four Things Youth Should Know About It, According To DoctorFrom the information available, of the 14 infants, the age ranged from 16 days to just over 5 months, and half of them were females. The FDA confirmed that the infants who fell ill were all fed ByHeart Whole Nutrition powdered infant formula.The multistate outbreak is now being investigated by FDA, CDC, and California Department of Public Health Infant Botulism Treatment and Prevention Program, and other state and local health authorities, the advisory stated. On Tuesday, ByHeart informed that the company is expanding its earlier recall in order to include all batches of the baby formula and the Anywhere Pack single-serve sticks nationwide. "The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority. This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve," said Mia Funt, the president and co-founder of the company.Also Read: Exposure to Toxic, Poisonous Air Does Not Build Pollution Immunity, Doctors Warn! What Is Infant Botulism?Most common form of all botulism in babies, who are between 2 to 8 months old. It happens when the bacteria spores grow in a baby’s intestines and produce the toxin. Honey and contaminated soil can be sources of infant botulism. Adults can also get this type, though it’s rare.What Are The Symptoms Of Botulism In Infants?As per CDC, the symptoms include:Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowingIf untreated, infants with infant botulism experience a progressive flaccid paralysis that can lead to breathing difficulties and required weeks of hospitalization.States Hit By Infant Botulism Outbreak:As per the FDA advisory, here is the list of states affected by infant botulism:ArizonaCaliforniaIllinoisKentuckyMinnesotaNorth CarolinaNew JerseyOregonPennsylvaniaRhode IslandTexasWashingtonThe company ByHeart Inc's two lots of Whole Nutrition Infant Formula has been recalled, the lots are:Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")What Parents Should Do?As per the FDA advisory, parents and caregivers should stop using any ByHeart infant formula products immediately. Furthermore, the advisory notes:If your child consumed ByHeart formula and is experiencing symptoms (see below) seek immediate medical attention.If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.If you still have the formula in your home, you should:                                  •take a photo or record the information on the bottom of the package.                                  •keep the container in a safe spot and be sure to label that product as DO NOT USE.                                  •If your child develops symptoms your state health department might want to collect your                                                formula container for testing. If your child does not develop symptoms after 30 days, throw                                            your containers out.

byheart formula recall update: 2 more infants hospitalized, fda says

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