The recalled formula was sold at ByHeart.com and at major retailers nationwide, the FDA says. ByHeart is sold at Amazon, Kroger, Sam’s Club, Target, Walmart, and Whole Foods, among other stores. The illnesses were first reported in August 2025, with the last illness onset reported in November 2025.
Lot Numbers Recalled
• Batch Code: 251261P2; use-by date: 01 Dec 2026
• Batch Code: 251131P2; use-by date: 01 Dec 2026
• UPC: 5004496800
The problem: 13 infants across 10 states who have consumed ByHeart powdered infant formula have been hospitalized with infant botulism.
Company response: In a statement on the company’s website, ByHeart says that “testing from a previously opened can lacks scientific basis to establish causation between the product and illness.”
The company says that it has enlisted a third-party independent testing laboratory to test the two recalled batches of infant formula from unopened cans and is awaiting expedited results. “These results will confirm if C. botulinum bacteria is present in ByHeart’s infant formula,” Kuehn said in an email to CR. “We commit to sharing these results as soon as they become available.”
“We take the California Department of Public Health’s (CDPH) results seriously and we are actively working in partnership with CDPH, FDA, and CDC on their comprehensive investigation,” Kuehn said. “We are committed to getting to the bottom of it.”
According to publicly available data from the FDA, a January 2024 inspection by the FDA of ByHeart’s Pennsylvania infant formula manufacturing facility resulted in several citations for unsanitary conditions and the potential for contamination of raw materials at the facility. There was also a citation for lack of pest control.
“It’s very troubling that ByHeart appears to not have adequately addressed the FDA’s concerns over the serious problem involving unsanitary and contamination risk conditions at their plant,” says Brian Ronholm, head of food policy for CR. Drastic budget cuts and a federal government shutdown also limit the “ability of regulators to manage how the outbreak is communicated,” Ronholm says. It’s unclear how long the ByHeart formula investigation may take.
What consumers can do next: Stop using any cans with the recalled batch codes and check with your local health department before disposing of the cans. You can email ByHeart at [email protected] for information, or call 833-429-4327.
If you have recalled formula, wash any items or surfaces that may have come into contact with the formula using hot soapy water or in a dishwasher, the CDC says.
To report an illness, contact your state’s local health department, fill out the FDA’s MedWatch Online Voluntary Reporting Form, or call an FDA Consumer Complaint coordinator.
An infant formula shortage is not likely. According to the FDA, ByHeart produces approximately 1 percent of the nation’s infant formula, and this recall is not expected to cause a formula shortage or drastically affect the country’s formula supply.
As a reminder, medical experts strongly advise against making your own baby formula because it can result in dangerous nutritional deficiencies or contamination.
Learn more about how Consumer Reports tests infant formula for contaminants such as heavy metals, acrylamide, and bisphenol A (BPA), and find the products that exceed our safety expectations.
