In early November, ByHeart Whole Nutrition Infant Formula was recalled over a link to an infant botulism outbreak. Consumers were warned not to use the product in their possession, and retailers were instructed to remove it from shelves.
The FDA now says that’s not what happened. Instead, major retailers continued to offer the product to consumers, in one case even offering a discount after the recall began!
Parents, knowing the FDA regulates product safety, expect that they can pick up a can of formula from a local store shelf and assume it’s safe. This jarring incident underscores the need for due diligence in monitoring recalls.
The FDA Recalls ByHeart Whole Nutrition Formula
An archived copy of the FDA’s recall warning documents that on November 11th, retailers and consumers were told that “all unexpired lots of formula cans and single-serve ‘anywhere’ sticks” of ByHeart Whole Nutrition Infant Formula products were being recalled due to a connection with a botulism outbreak affecting at least 15 infants in 12 states, all of whom were severely ill enough to be hospitalized. (An initial recall on the 8th was narrower; at this point, it expanded to include all products.)
Parents were advised to discontinue use of the product and monitor for symptoms. Retailers were told to pull the product from shelves.
In subsequent updates, the FDA confirmed that product analysis showed the formula was the source of the outbreak and that an ongoing investigation is seeking the point of contamination.
Retailers Did Not Quickly Withdraw The Product, However
The FDA has issued warning letters to major corporations, including Walmart, Target, Albertsons, and Kroger, giving the companies 15 business days in which to explain how they’ll address the failure.
The warning letter issued to Walmart notes that regulators then entered Walmart stores and found the product still on the shelves. The public release has the total number of stores that continued to sell the product after the recall redacted under a Freedom of Information Act exception (labeled “(B)(4)” in the excerpt below) but notes that they were in at least 21 states.
“However, based on FDA’s review of information from state and local partners, the Agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (b)(4) Walmart store locations across 21 states from November 12 to November 26, 2025. This represents a period of (b)(4) days after Walmart was notified of the recall expansion.”
At Least One Store Even Promoted The Recalled Product
The FDA also sent warning letters to Kroger, Albertsons, and Target. Each letter acknowledges that the FDA has already held a phone call with the company to address the issue and has sent multiple follow-up emails, but that the companies (yes, all four) have failed to respond with any information on how they intend to prevent similar incidents.
The Walmart letter reads as follows:
“Despite follow-up emails from the FDA on November 20, 21, and 24, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.”
The letters from Target, Kroger, and Albertsons use similar language, but the Target letter also notes an even more egregious act. According to the FDA, at least one Target store actually promoted the recalled formula with discounts!
“The inadequacy of Target’s recall response was further demonstrated on November 20, 2025, when Arkansas state partners observed ByHeart Whole Nutrition Infant Formula single-serve “anywhere pack” sticks on a Target store shelf with promotional “Sale!” signage offering a $2.00 discount on the recalled formula from November 16 to November 22, 2025.”
What Are Retailers Saying About The Error?
So far, few retailers have made any public response.
However, according to WHQR, Walmart issued a statement saying it immediately blocked the products in its checkout systems and did not sell any of the formula once the recall was announced, even if it was still on shelves.
Although the FDA says the stores haven’t filed formal responses, each warning letter lists reasons the agency says were offered by store associates.
These include confusion about the recall, lack of information about the recall, failure to fully remove all product upon receiving the notice, and mistaken stocking of newly-arrived product after the recalled formula was initially pulled from shelves.
Upon receipt of the warning letters (all dated December 12) the companies have 15 working days in which to respond with clear explanations of procedures implemented to prevent a repeat of this incident.
What Should Parents Do?
If you see changes in your child’s behavior that concern you, check in with your doctor, your local health department, or other medical professional. With regard to botulism, the FDA offers the following information:
“Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.”
Keep an ear out for recall information on products you use, especially infant products such as formula, baby foods, and seats and carriers. Recalled products should be pulled from shelves, but as this incident shows, that won’t always be carried out perfectly, and your attention to current events could help keep your baby safe.