Publisher’s Platform: Is ByHeart Formula still on Store Shelves? Have kids become infected with Botulism AFTER the Recall?

Rumor has it that cans of ByHeart can still be found on store shelves.

Here are some facts. The incubation period for infant botulism is 3 to 30 days. The first recall occurred on November 8, when only 13 children were reported sick. As late as December 3rd (maybe later) they (the FDA and state public health) were still finding cans on the shelves. Any illness after mid-November could very well be from a product that should have been recalled but was purchased and consumed anyway. And more illnesses could still be reported in the coming weeks. Besides stores, what about places like food banks? Or all foreign sales? Or at the bottom of family pantries?

Seriously, like I said the other day, babies get botulism and stores can’t seem to get the poison off the shelves?

If a store sells this product AFTER the recall date and a child becomes ill, they are liable for punitive damages.

Here are some excerpts from the FDA warning letters from a few days ago. The links below are the full letters.

Target

On November 19, 2025, the FDA called you to discuss the ineffectiveness of the recall at your Target stores. During this discussion, FDA requested information on what actions you were prepared to take to ensure that the recalled product is no longer available for purchase at Target stores nationwide. Despite follow-up emails from FDA on November 20, 21, 24, and 26, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effect this recall have been implemented throughout your organization to prevent adulterated foods from being received in interstate commerce and subsequently offered for sale.

The inadequacy of the response to Target’s recall was further demonstrated on November 20, 2025, when Arkansas state partners observed single-serve ByHeart Whole Nutrition infant formula sticks “pack anywhere” on a Target store shelf with a promotional message “Sale!” display offering a $2.00 discount on recalled infant formula from November 16-22, 2025. This observation indicates not only Target’s failure to remove recalled infant formula from store shelves, but also the active promotion and discounted sale of recalled infant formula implicated in an infant botulism outbreak, more than one (b)(4) after Target was first informed of the expanded ByHeart recall.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/target-corporation-720399-12122025

Walmart

However, based on FDA’s review of information from state and local partners, the Agency has determined that recalled ByHeart Whole Nutrition infant formula remains on shelves at (b)(4) Walmart store locations in 21 states from November 12 to November 26, 2025. This represents a period of (b)(4) days after Walmart was informed of the expanded recall. State and local partners reported several explanations offered by Walmart store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion over the specific lots affected, failure to remove all affected products, and storage of products that arrived after the recall notification.

On November 18, 2025, the FDA called you to discuss the ineffectiveness of the recall at your Walmart stores. During this discussion, FDA requested information on what actions you were prepared to take to ensure that recalled products are no longer available for purchase at Walmart stores nationwide. Despite follow-up emails from 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 effect this recall have been implemented throughout your organization to prevent adulterated foods from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-720400-12122025

Kroger

However, based on FDA’s review of information from state and local partners, the Agency has determined that recalled ByHeart Whole Nutrition infant formula remains on shelves at (b)(4) Kroger store locations in 10 states from November 12, 2025 to November 19, 2025. This represents a period of (b)(4) days after Kroger was first informed of the initial recall and (b)(4) days after Kroger was informed of the expanded recall. State and local partners reported several explanations offered by Kroger store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion over the specific lots affected, failure to remove all affected products, and storage of products that arrived after the recall notification.

On November 19, 2025, the FDA called you to discuss the ineffectiveness of the recall in your Kroger stores. During this discussion, the FDA requested information on what actions you were prepared to take to ensure that the recalled product is no longer available for purchase at Kroger stores nationwide. Despite follow-up emails from FDA on November 20, 21, 24, and 25, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effect this recall have been implemented throughout your organization to prevent adulterated foods from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kroger-company-720464-12122025

Albertson

However, based on FDA’s review of information from state and local partners, the Agency has determined that recalled ByHeart Whole Nutrition infant formula remains on shelves at (b)(4) Albertsons store locations in 11 states from November 12-19, 2025. This represents a period of (b)(4) days after Albertsons was first informed of the initial recall and (b)(4) days after Albertsons was informed of the recall extension. State and local partners reported several explanations offered by Albertsons store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion over the specific lots affected, failure to remove all affected products, and storage of products that arrived after the recall notification.

On November 20, 2025, the FDA called you to discuss the ineffectiveness of the recall at your Albertsons stores. During this discussion, the FDA requested information on what actions you were prepared to take to ensure that the recalled product is no longer available for purchase at Albertsons stores nationwide. Despite follow-up emails from FDA on November 20 and 24, 2025, and December 1 and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effect this recall have been implemented throughout your organization to prevent adulterated foods from being received in interstate commerce and subsequently offered for sale.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/albertsons-companies-incorporated-720465-12122025

We must do better.