All types of ByHeart Whole Nutrition Infant Formula products were recalled after at least 51 babies got botulism, including babies in Texas. Lawsuits are now being filed nationwide.

Need a Texas ByHeart Botulism Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If your baby got botulism from ByHeart Baby Formula, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

UPDATE: Texas Parents File ByHeart Botulism Lawsuit

In December 2025, the parents of a baby in Texas filed a botulism lawsuit against ByHeart, the manufacturer of contaminated infant formula. The baby boy was just 4 months old when he developed symptoms of botulism and had to be hospitalized, intubated, and receive nutrition through a feeding tube. He still suffers from weakness. His parents worry about long-term side effects.

ByHeart Formula Linked to 51 Cases of Botulism

As of December 10, 2025, at least 51 babies who consumed ByHeart Infant Formula have been diagnosed with infant botulism in 19 states since 2023, according to the FDA Outbreak Update.

The expanded outbreak now includes all reports of babies who consumed ByHeart formula and were diagnosed with botulism at any time after ByHeart formula hit the market in 2022. Botulism can be deadly, but all of the babies were hospitalized and successfully treated with the botulism antitoxin.

Texas Reports 8 Cases of Infant Botulism From ByHeart Formula

Texas is one of the hardest-hit states in the botulism outbreak linked to ByHeart formula. At least 8 babies in Texas have been diagnosed with botulism, according to the CDC.

1st ByHeart Botulism Lawsuits Filed for Babies Who Got Sick

The first lawsuits have been filed against ByHeart by the parents of babies who were diagnosed with infant botulism in Kentucky and Arizona.

Baby Botulism Outbreak Linked to ByHeart Infant Formula

In November 2025, the FDA warned parents and caregivers about an outbreak of infant botulism that has been linked to ByHeart Whole Nutrition Infant Formula.

Parents should stop using ByHeart Formula immediately, according to Dr. Erica Pan, CDPH Director and State Public Health Officer:

“We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

Where Did Babies Get Botulism?

As of December 10, 2025, a total of 19 states have reported 51 cases of botulism in babies who were fed ByHeart Infant Formula, but there may be additional cases (or unreported cases) in other states, according to the CDC Outbreak Investigation. The 19 states in the ByHeart botulism outbreak include:

  • Arizona
  • California
  • Idaho
  • Illinois
  • Kentucky
  • Massachusetts
  • Maine
  • Michigan
  • Minnesota
  • North Carolina
  • New Jersey
  • Ohio
  • Oregon
  • Pennsylvania
  • Rhode Island
  • Texas
  • Virginia
  • Washington
  • Wisconsin

ByHeart Infant Formula Recall

On November 10, 2025, ByHeart voluntarily expanded the recall to include every single can of ByHeart Whole Nutrition Infant Formula, and also single-serve “anywhere” sticks, after more cases of botulism were reported. ByHeart sold about 200,000 cans of formula per month at Target, Walmart, Albertsons, Whole Foods, Kroger, Amazon, other stores and online.

Signs & Symptoms of Baby Botulism

It can take weeks for botulism to cause symptoms in babies, but the symptoms may include:

  • Constipation
  • “Floppy” baby
  • Poor feeding
  • Drooping eyelid and slow pupils
  • Difficulty sucking and swallowing
  • Weak or altered cry
  • Generalized weakness
  • Difficulty breathing
  • Breathing stops or is too slow to survive (respiratory arrest)

FDA Asks Parents to Record Info Before Throwing Out ByHeart Formula

Babies may not develop symptoms of botulism for up to 30 days after eating contaminated formula, so the FDA is urging parents to take a photo or write down the information on the bottom of the can before throwing it out. If your baby gets sick, this information will be critical.

ByHeart Defends Safety Of Their Formula

In the recall and on its website, ByHeart defended the safety of their formula, and invited officials to test unopened cans of formula.

ByHeart said there were “83 cases of infant botulism reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point.”

Even after health officials in California found botulism bacteria spores in an open can of ByHeart Infant Formula that was collected from the home of a baby who got botulism, ByHeart minimized their responsibility:

“Without test results from an unopened can, there is no confirmed link between ByHeart’s infant formula and infant botulism.”

What Causes Infant Botulism?

Infant botulism is a rare disease that occurs when a baby swallows the spores of the bacteria that causes botulism, called Clostridium botulinum. The spores grow in the baby’s immature digestive system, where they produce a powerful neurotoxin that attacks the nerves, resulting in progressive muscle paralysis.

How Toxic Is Botulism?

Botulism toxin is one the most deadly poisonous substances known. You cannot see, smell, or taste the toxin that causes botulism, but eating even a small sip of food containing the toxin can be deadly.

Botulism causes progressive muscle weakness, including trouble breathing. It can lead to breathing failure or death if not treated in time.

Baby Botulism May Not Cause Symptoms for Weeks?

It can take weeks, or as long as 30 days, for symptoms of infant botulism to begin. The signs may include a “floppy” body, weak head and neck muscles, problems sucking and swallowing, constipation, and progressive weakness of the arms, legs, and breathing muscles.

Honey Is Another Common Source of Baby Botulism

Botulism is caused by a bacteria called Clostridium botulinum, which is commonly found in soil and dust. Honey is also a well-known source of the spores that cause botulism, which is why parents and caregivers should never give honey to infants under 1 year old.

Early Treatment With Botulism Antitoxin

The botulism outbreak was linked to ByHeart by the California Infant Botulism Treatment and Prevention Program, a state program that tracks cases of infant botulism and tests suspected products.

All babies in the outbreak were hospitalized and given the only FDA-approved botulism antitoxin, BabyBIG® (Botulism Immune Globulin).

Early treatment with the BabyBIG antitoxin is essential. It should not be delayed while waiting for lab results. Doctors who suspect a case of botulism can contact the program at (510) 231-7600 at any time.

Need a ByHeart Botulism Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.

Meet Your Attorney

Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

To contact Collen, please fill out the contact form below:

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