Seriously, kids are getting botulism and you can't get the poison off your shelves? If any of you have sold this item AFTER date of revocation and the child becomes ill, you are subject to penalties.
Here are some excerpts from the FDA warning letters issued a few days ago. The links below are the full letters.
Target
On November 19, 2025, the FDA spoke with you by telephone to discuss the ineffectiveness of the recall in your Target stores. During the discussion, the FDA requested information about the actions you were willing to take to ensure that the recalled product would no longer be available for purchase at Target stores nationwide. Despite subsequent emails from the FDA dated November 20, 21, 24, and 26, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that your organization has taken corrective actions to implement this recall to prevent adulterated food products from entering interstate commerce and subsequently being offered for sale.
The inadequacy of Target's response was further demonstrated on November 20, 2025, when Arkansas partners noticed single-use ByHeart Whole Nutrition Infant Formula sticks “in any package” on a Target store shelf with the advertising message “Sale!” sign offering a $2 discount on recalled infant formula from November 16 to November 22, 2025. This observation indicates not only Target's failure to remove recalled infant formula from store shelves, but also the active promotion and discounting of recalled infant formula implicated in the infant botulism outbreak, rather than simply (b)(4) after Target first learned of ByHeart's extended recall.
Walmart
However, based on FDA's review of information received from state and local partners, the agency has determined that the recalled ByHeart Whole Nutrition infant formula remains on store shelves. (b)(4) Walmart store locations in 21 states from November 12 to November 26, 2025. This is the period (b)(4) days after Walmart was notified that the recall was expanding. State and local partners reported several explanations offered by Walmart store employees for the continued availability of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all affected products, and stocking of products that arrived after the recall notice.
On November 18, 2025, the FDA spoke with you by telephone to discuss the ineffectiveness of the recall in your Walmart stores. During this discussion, the FDA requested information about the actions you were willing to take to ensure that the recalled product would no longer be available for purchase at Walmart stores nationwide. Despite subsequent emails from the FDA on November 20, 21, and 24, 2025, and December 1, 3, and 8, 2025, you have not provided the FDA with any information demonstrating that corrective actions to implement this recall have been implemented throughout your organization to prevent the receipt of adulterated food products in interstate commerce and their subsequent offering for sale.
Hooks
However, based on FDA's review of information received from state and local partners, the agency has determined that the recalled ByHeart Whole Nutrition infant formula remains on store shelves. (b)(4) Kroger stores in 10 states from November 12 to 19, 2025. (b)(4) days after Kroger was first notified of the initial recall and (b)(4) days after Kroger was notified of the extended recall. State and local partners reported several explanations offered by Kroger store employees for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all affected products, and storage of products that arrived after the recall notice.
On November 19, 2025, FDA spoke with you by telephone to discuss the ineffectiveness of the recall in your Kroger stores. During the discussion, the FDA requested information on the actions you are willing to take to ensure that the recalled product is no longer available for purchase at Kroger stores nationwide. Despite subsequent emails from the FDA on November 20, 21, 24, and 25, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information to demonstrate that your organization has taken corrective actions to implement this recall to prevent adulterated food products from entering interstate commerce and subsequently being offered for sale.
Albertsons
However, based on FDA's review of information received from state and local partners, the agency has determined that the recalled ByHeart Whole Nutrition infant formula remains on store shelves. (b)(4) Albertsons stores in 11 states from November 12 to 19, 2025. This is the period (b)(4) days after Albertsons was first notified of the initial recall and (b)(4) days after Albertson was notified of the recall extension. State and local partners reported several explanations offered by Albertsons store employees for the continued availability of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all affected products, and storage of products that arrived after the recall notice.
On November 20, 2025, FDA spoke with you by telephone to discuss the ineffectiveness of the recall in your Albertsons stores. During the discussion, the FDA requested information on the actions you are willing to take to ensure that the recalled product is no longer available for purchase at Albertsons stores nationwide. Despite subsequent emails from the FDA on November 20 and 24, 2025, and December 1 and 8, 2025, you have not provided FDA with any information to demonstrate that your organization has taken corrective actions to implement this recall to prevent adulterated food products from entering interstate commerce and subsequently being offered for sale.
