Name: Johnson // Becker
Address: 444 Cedar St #1800, Saint Paul, Minnesota, 55101, US
Telephone: (800) 279-6386
Rating: 5

Federal and state health officials are investigating a nationwide infant botulism outbreak linked to ByHeart baby formula. Infant botulism occurs when an infant ingests bacteria that colonize the intestines and produce botulinum toxin. Early signs include constipation, feeding difficulties, weak cry, and poor head control.

We offer a Free Case Evaluation. If your loved one was injured by ByHeart baby formula, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new baby formula lawsuits nationwide, and you may be entitled to financial compensation.

Please contact us using the form below or by calling us at (800) 279-6386.

We would be honored to speak with you and respond promptly to every inquiry we receive.

Timeline of ByHeart Baby Formula Recall

Nov. 20, 2025 – FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations. FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.
Nov. 19, 2025 – As of November 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states (see map). Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized. No deaths have been reported to date. For 23 infants with age and 24 with sex information available, they range in age from 16 to 200 days and 11 (46%) are female.

Infant Botulism Case Counts

Total Illnesses: 31 (8 New)
Hospitalizations: 31 (8 New)
Deaths: 0
Last Illness Onset: November 13, 2025
States with Cases: AZ, CA, ID, IL, KY, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide

Nov. 14, 2025 – FDA reports that as of November 14, 2025, a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 states. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum.
Nov. 11, 2025 – the U.S. Food & Drug Administration announced that the recall had been expanded to include all all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide.
Nov. 8, 2025 – Byheart announced a recall of certain lots of their Whole Nutrition Infant Formula.

Below are some links to helpful U.S. Federal Government and State Agencies coordinating this baby formula recall.

- FDA (11/19/25): The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism.
- FDA (11/14/25): Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.
  FDA (11/9/25): In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula
- FDA (11/11/25): ByHeart Broadens Voluntary Recall While Investigation Continues
- FDA (11/11/25): Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
- CDC: Infant Botulism Outbreak Linked to Infant Formula, November 2025
- California Department of Health: Infant Botulism Treatment & Prevention Program
- Infant Botulism Treatment: Learn more about the BabyBIG Infant Botulism Treatment Program

Due to contamination of the product, the baby formula may contain a toxin that could cause infant botulism. Botulism may lead to serious illness, and in some cases, could be fatal.

There are at least 31 reports countrywide of infant botulism linked to the formula. The investigation and outbreak is ongoing.

Is the Byheart Baby Formula Recalled?

Yes. ByHeart Inc. has announced a nationwide product safety recall.

CDC and FDA are concerned that other lots of ByHeart Whole Nutrition infant formula may be contaminated and are making infants sick with infant botulism.

ByHeart initially recalled specific lots on November 8, 2025, but infants in the outbreak had consumed different lots not included in that recall. On November 11, 2025, ByHeart expanded the recall to include all ByHeart Whole Nutrition infant formula products.

Recently, the U.S. FDA Commissioner inspected a ByHeart manufacturing facility and confirmed presence of Clostridium botulinum, which is causing infant illness in multiple regions of the country.

The FDA and CDC advises all parents and caregivers to stop using all ByHeart Whole Nutrition infant formula immediately. All lot numbers and all package sizes of ByHeart baby formula have now been recalled.

The recalled formula was sold online and in retail stores such as Walmart, Target, Kroger, Whole Foods, Publix & more.

Pediatrician Discusses Baby Formula Recall & Symptoms / Treatment of Infant Botulism

Infant Botulism Linked to ByHeart Infant Formula

Infant botulism symptoms can take several weeks to appear. Monitor your infant if they’ve consumed ByHeart Whole Nutrition infant formula.

If you feel that your baby is experiencing a medical emergency, please call 911 or go to the nearest emergency room.

Symptoms of Infant Botulism

Infant botulism typically starts with constipation, poor feeding, weak head control, and trouble swallowing.
Without treatment, the paralysis progresses and can cause breathing problems requiring weeks of hospitalization.
BabyBIG treatment is recommended for all suspected cases.

What is BabyBIG

The BabyBIG treatment was developed by the California Department of Public Health and is distributed through them. It’s been available since 2003 and has significantly improved outcomes for infant botulism cases.

The mission of the IBTPP is to provide and improve the treatment of infant botulism and to prevent infant botulism and related diseases.

BabyBIG (Botulism Immune Globulin Intravenous) is an antitoxin treatment specifically for infant botulism. It contains antibodies that neutralize the botulinum toxin in the bloodstream.

It reduces the severity and duration of illness, shortens hospital stays, and decreases the need for mechanical ventilation. The treatment is most effective when given early after symptom onset.

Infant Botulism Treatment and Prevention Program (IBTPP) – BabyBIG Program

Here is a link to the California Department of Public Health website providing details on to use of BabyBIG Infant botulism treatment:

Infant Botulism Treatment and Prevention Program – BabyBIG

The IBTPP has provided a section on their website to assist parents, caregivers and healthcare professionals. Please visit their website for up-to-date information on using the BabyBIG treatment protocol and to learn more about the current and ongoing infant botulism outbreak linked to ByHeart baby formula.

Why Choose Johnson//Becker for Your Baby Formula Lawsuit?

Johnson//Becker is dedicated to serving you or your family with care, compassion, and commitment. Our lawyers have significant legal qualifications and over two decades of experience to best represent your interests in matters of injury due to dangerous consumer products.

Learn More: Why Choose Us

Questions About a ByHeart Baby Formula Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.

If your loved one was injured by ByHeart baby formula, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new baby formula lawsuits nationwide, and you may be entitled to financial compensation.

We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.