Recalled Infant Formula Linked to Botulism Outbreak May Remain on Store Shelves

Recalled ByHeart Infant Formula May Remain on Store Shelves Amid Botulism Outbreak

Federal health officials report that infant formula linked to a botulism outbreak, despite being recalled, may still be available on store shelves.

As of Wednesday, the Food and Drug Administration (FDA) confirmed 31 cases of suspected or confirmed infant botulism. These cases were reported in babies who consumed ByHeart Whole Nutrition formula between August and mid-November. The affected infants were hospitalized, with no fatalities reported. Infant botulism can induce a progressive, potentially life-threatening form of paralysis in infants under one year of age.

Epidemiologic and laboratory data indicate that ByHeart Whole Nutrition infant formula may be contaminated with Clostridium botulinum, the bacterium responsible for the reported infant illnesses across multiple U.S. regions. The 31 cases were reported across 15 states:

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

ByHeart Whole Nutrition initially recalled two batches of its infant formula earlier in the month, subsequently expanding the recall to include all of its products last week. These products, encompassing cans and single-serve packets, are distributed nationwide through major retailers such as Target, Publix, Walmart, and Whole Foods, as well as online. Some products were also shipped to international customers. ByHeart, established in 2022, accounts for approximately 1% of the U.S. infant formula market, and the FDA has not expressed concerns about a potential supply shortage.

ByHeart stated it is collaborating with the FDA and investigating its processes to identify the outbreak's origin. The company, alongside the FDA, advises consumers to cease using the formula and to monitor infants for botulism symptoms. The FDA has also instructed retailers to discontinue sales of the product. The agency noted in a Wednesday update that recalled formula continues to be found on store shelves in multiple states and is working with state partners and retailers to ensure recall effectiveness.

The outbreak has escalated since the FDA's initial investigation announcement on November 8, when 13 of an estimated 83 infant botulism cases nationwide had consumed ByHeart formula. The FDA noted the unusual nature of botulism in dairy products and the absence of historical precedent for infant formula causing the illness.

Following the initial recall, the California Department of Public Health tested a sample from one of the recalled batches, confirming the presence of Clostridium botulinum. While this sample originated from an opened can, ByHeart's FAQ now states that further third-party testing also identified the bacteria in samples of unopened formula. ByHeart initiated a full recall of its products on November 11 after the FDA reported two additional infant botulism cases linked to its formula.

Infant botulism is a rare but serious illness caused by Clostridium botulinum. Upon ingestion of the spores by an infant, they proliferate in the gut and produce toxins. Symptoms typically manifest three to 30 days post-consumption and often commence with constipation, diminished feeding, swallowing difficulties, and loss of head control. Untreated, the illness can lead to progressive, flaccid paralysis, potentially causing respiratory difficulties and necessitating weeks of hospitalization. Treatment involves an antitoxin known as BabyBIG, administered intravenously.

The Centers for Control and Prevention (CDC) recommends that parents remain vigilant for several weeks after their infant's last consumption of ByHeart formula. They are advised to sanitize contaminated surfaces, label any remaining powder "DO NOT USE," and store it securely for one month for potential state health department testing. Parents should seek immediate medical attention if any concerning symptoms arise. The California Department of Public Health has established an infant botulism outbreak hotline for assistance.

ByHeart affirmed it is conducting its own extensive testing and providing the FDA with full access to its facilities and products for the investigation. The company has enhanced customer resources, including a 24/7 support hotline and refunds for purchases made since October. ByHeart has also committed to implementing more robust safeguards and testing, stating that Clostridium botulinum was not among the pathogens routinely tested for within the industry prior to this event.

Separate federal lawsuits have been filed by the parents of two four-month-old infants hospitalized with botulism in Arizona and Kentucky. These lawsuits allege negligence by ByHeart and seek compensation for medical expenses and emotional distress. Additionally, a class-action lawsuit filed in New York asserts deceptive marketing practices. ByHeart declined to comment on the lawsuits, reiterating its focus on ensuring recall awareness and supporting the FDA's investigation.