Robert Peirce & Associates, P.C. is actively investigating potential claims on behalf of families in Pennsylvania, Ohio, and West Virginia whose infants may have developed botulism after consuming recalled ByHeart Whole Nutrition Infant Formula.
The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and California Department of Public Health (CDPH) are investigating a multistate outbreak of infant botulism linked to ByHeart formula.
As of November 11, 2025, at least 15 infants in 12 states have been hospitalized with confirmed or suspected illness. No deaths have been reported, but all affected infants required intensive medical care.
FDA and CDC Investigation & ByHeart Recall Overview
The Federal Investigation
The FDA, CDC, and CDPH are working together to determine how Clostridium botulinum bacteria may have contaminated certain batches of ByHeart formula.
According to the FDA's ongoing investigation, laboratory testing conducted by the CDPH identified the bacteria in an opened can of formula fed to an affected infant.
Investigators are now focusing on ByHeart’s manufacturing facility in Allerton, Iowa, and its packaging site in Portland, Oregon, to identify potential points of contamination. Both opened and unopened formula samples are being tested, alongside environmental swabs from those sites. Families of affected infants are also being interviewed to better understand feeding histories and exposure patterns.
Although Clostridium botulinum can be difficult to detect in powdered formula, federal officials have said the connection between ByHeart products and the current outbreak appears statistically significant. ByHeart accounts for less than 1% of U.S. formula sales, yet its products are disproportionately represented among sick infants.
The Nationwide Recall
Following the emergence of new cases and at the FDA’s recommendation, ByHeart, Inc. announced on November 11, 2025, that it would expand its voluntary recall to include all unexpired batches of Whole Nutrition Infant Formula—both 24-ounce cans and single-serve Anywhere Pack™ sticks.
ByHeart said this decision was made “out of an abundance of caution” as testing continues. Although no unopened cans have tested positive for contamination, the company has begun additional third-party testing and is providing federal regulators full access to its facilities and retained samples.
The expanded recall covers products sold both online and through major retailers such as Target, Walmart, Albertsons, and Whole Foods.
Parents and caregivers are advised to:
- Immediately stop using all ByHeart products.
- Keep the containers, clearly labeled “DO NOT USE,” in case they are requested for testing by health officials.
- Seek medical care right away if an infant exhibits symptoms such as constipation, weak muscle tone, poor feeding, drooping eyelids, or difficulty breathing.
- Report any illness to the FDA through its MedWatch online portal.
The investigation remains active, and both the FDA and ByHeart have committed to updating the public as more information and test results become available.
Understanding Infant Botulism
Infant botulism is a rare but potentially life-threatening illness caused when bacteria produce toxins in a baby’s intestines. Because infants under one year old have immature gut flora, they are particularly vulnerable to colonization by Clostridium botulinum.
Symptoms may begin gradually and progress over days or weeks after ingestion. Typical early warning signs include:
- Constipation and reduced feeding
- Loss of head control
- Weak cry or decreased facial expression
- Difficulty swallowing or breathing
All reported ByHeart-related cases have required hospitalization for supportive care and administration of BabyBIG® (Botulism Immune Globulin Intravenous), the only available treatment.
Is There Litigation Involving ByHeart Formula?
While no federal or class-action lawsuits have yet been filed, litigation is likely as the FDA and CDC continue to confirm cases and trace the source of contamination. If evidence shows that ByHeart’s manufacturing, testing, or distribution process allowed contamination to occur, or that the company failed to adequately warn consumers, families may have viable product liability claims.
Potential legal actions could seek compensation for:
- Hospitalization and medical expenses
- Pain and suffering experienced by the child
- Emotional distress of parents and caregivers
- Long-term neurological or developmental complications
Your Rights as a Parent or Caregiver
Parents who purchased or used ByHeart infant formula and whose child became ill, or who have questions about possible exposure, should know their rights. Companies that manufacture or distribute contaminated or unsafe baby formula may be held legally accountable for the harm their products cause.
Even if your child has recovered, you may still be entitled to pursue a claim to cover medical costs and emotional trauma. An experienced attorney can help determine whether negligence, contamination, or inadequate testing may have played a role in your child’s illness.
How Robert Peirce & Associates, P.C. Can Help
For more than 40 years, Robert Peirce & Associates, P.C. has represented families across Pennsylvania, Ohio, and West Virginia in complex product liability, toxic exposure, and food poisoning cases. Our trial lawyers have the experience, investigative resources, and expert network needed to take on large corporations and manufacturers.
If your family has been affected by the ByHeart infant formula recall or a suspected case of infant botulism, we encourage you to reach out. We can help you understand your legal options and preserve crucial evidence that may support your claim.
Call (844) 383-0565 or contact us online to speak confidentially with an attorney today.