ByHeart Baby Formula Lawsuit

Lawsuits are now being filed after every can of ByHeart Baby Formula was recalled due to a botulism outbreak that sickened at least 51 babies.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting ByHeart Baby Formula cases in all 50 states. If your baby got botulism from ByHeart Whole Nutrition Infant Formula, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Baby Formula Recall Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Botulism Outbreak Expands to All ByHeart Formula Ever Sold

Health officials have dramatically expanded a botulism outbreak linked to ByHeart Infant Formula. The outbreak now includes all babies who got botulism after consuming ByHeart formula at any time since it hit the market in March 2022.

The FDA said it “cannot rule out the possibility” that all ByHeart formula ever made since 2022 could have been contaminated with botulism and other bacteria.

ByHeart Baby Formula Linked to 51 Cases of Botulism

As of December 10, 2025, at least 51 babies in 19 states have been diagnosed with infant botulism after they consumed ByHeart Whole Nutrition Infant Formula since it hit the market in March 2022, according to an FDA Outbreak Update.

The 19 states where botulism cases have been reported include:

• Arizona
• California
• Idaho
• Illinois
• Kentucky
• Massachusetts
• Maine
• Michigan
• Minnesota
• North Carolina
• New Jersey
• Ohio
• Oregon
• Pennsylvania
• Rhode Island
• Texas
• Virginia
• Wisconsin
• Washington
• There may be additional unreported cases of botulism in other states (and internationally).

1st Lawsuits Filed in ByHeart Botulism Outbreak

The first lawsuits have been filed by the parents of babies who got botulism after they were fed ByHeart Whole Nutrition Infant Formula. These lawsuits involve victims in Arizona, California, Texas, Kentucky, and other states.

Baby Botulism Outbreak Linked to ByHeart Formula

On November 11, 2025, every single can of ByHeart Whole Nutrition Infant Formula and single-serve “anywhere” sticks were recalled nationwide. Before the outbreak, ByHeart sold about 200,000 cans of formula per month at Whole Foods, Target, Walmart, Albertsons, Kroger, Amazon, other stores and online.

Preliminary Tests Are Positive for Botulism in ByHeart Formula

In an update on November 19, the FDA confirmed that Clostridium botulinum (the bacteria that causes botulism) was found in an opened can of ByHeart Baby Formula that was collected from the home of a baby who got botulism.

On November 8, health officials in California said that preliminary tests found the botulism germ in ByHeart Infant Formula that was fed to an infant who got botulism:

​”CDPH has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases.”

Where Did Babies Get Botulism?

According to the CDC Outbreak Investigation, ByHeart formula was linked to 39 cases of infant botulism in 18 states (as of December 3, 2025). The illnesses were reported between August 9 and November 13, 2025. All of the babies were hospitalized. Botulism can be deadly, but all babies survived after being treated with the botulism antitoxin BabyBIG® (Botulism Immune Globulin).

What Causes Infant Botulism?

Health officials warned that contaminated infant formula is a rare disease that can occur when infant formula is contaminated with spores of the bacteria Clostridium botulinum:

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.”

Infant Botulism May Not Cause Symptoms for Weeks

Infant botulism may not cause symptoms for up to 30 days (or several weeks) after a baby eats contaminated food. This is because it takes time for the spores of the botulism bacteria to grow and multiply in the baby’s digestive system, where they will produce a powerful neurotoxin that causes the symptoms of infant botulism.

What Are the Symptoms of Botulism in Babies?

The symptoms of infant botulism may include:

• Breathing that stops or slows
• Constipation
• Eyelids that sag or partially close
• “Floppy” body
• Absence of gagging
• Loss of head control
• Paralysis that spreads downward
• Poor feeding and weak suckling
• Respiratory failure
• Extreme tiredness (lethargy)
• Weak cry

ByHeart Had Previous Recall for Baby Formula in 2022

In December 2022, ByHeart Whole Nutrition Infant Formula was recalled nationwide in the U.S. due to a risk of serious, life-threatening infections with Cronobacter sakazakii bacteria.

On December 11, the FDA announced a recall for 5 batches of ByHeart Whole Nutrition Infant Formula due to a risk of Cronobacter infections.

The recall includes 5 product batches: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with Use-By: 01 JAN 24 or 01 JUL 24.

No infections or deaths were reported, but Cronobacter sakazakii was found in a facility where ByHeart baby formula is canned, which presents a risk of cross-contamination. No distributed ByHeart products tested positive for Cronobacter contamination.

What is Cronobacter?

Cronobacter sakazakii is a bacteria that can survive in very dry foods, such as powdered baby formula — and it is particularly dangerous for young infants.

Earlier in 2022, a deadly outbreak of Cronobacter in baby formula prompted a massive recall and a nationwide shortage of formula. The infections were linked to certain Similac, Alimentum, and EleCare baby formula products that were made by Abbott Laboratories.

What is the Risk?

Babies who are infected with Cronobacter sakazakii can quickly develop severe, life-threatening infections, such as sepsis (bloodstream infection) or meningitis (inflammation of the membranes around the brain and spinal cord).

Symptoms of Cronobacter Infections in Babies

The symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements, according to the Centers for Disease Control and Prevention (CDC).

Necrotizing Enterocolitis

Infections with Cronobacter can also cause life-threatening intestinal damage, which is also called Necrotizing Enterocolitis (NEC). Dozens of lawsuits have already been filed by parents of babies who developed NEC after being fed powdered formula, such as Similac or Enfamil.

Do I Have a ByHeart Baby Formula Lawsuit?

The Schmidt Firm, PLLC is currently accepting ByHeart Baby Formula Botulism cases in all 50 states. If your baby got botulism from infant formula, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Baby Formula Recall Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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