The Food and Drug Administration has warned four major retailers that they failed to meet statutory requirements to make sure their stores removed ByHeart infant formula after it was recalled.
The formula has been found to be the source of an outbreak of infant botulism that has sickened 51 babies across 19 states, with some of the illnesses dating back as far as December 2023.
The outbreak strain of botulism making babies sick has been found in unopened containers of ByHeart’s powdered infant formula. ByHeart initiated a recall of some of its product on Nov. 8 and expanded the recall on Nov. 11 to include all of its product.
Following the launch of the recall, the FDA began receiving notification from state and local health departments that some retailers had not removed the implicated products from their store shelves. As of Dec. 15, state local and federal inspectors had conducted more then 4,000 checks to make sure the recalled formula had been removed from store shelves. The vast number of those checks, more than 3,500 of them, were conducted by local and state authorities.
“Through this effort, we found that recalled infant formula continued to be found on store shelves — for over three weeks in one case, in over 175 locations across 36 states,” the FDA reported.
The four retailers that received individual warning letters because of the failures were Albertsons, Kroger, Target and Walmart. In all of the warning letters the FDA reminded the retailers that “the receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation” of federal law.
The companies have 15 days to respond to the Dec. 15 warning letters with details about how they will correct their recall procedures or why they should not have to.
In an industry-wide letter the FDA described failures of retailers to properly recall the ByHeart formula.
“In one case, recalled product remained available for sale over three weeks after the recall was initiated, and in another case, the recalled product was offered at a discounted price, with the promotional period beginning five days after the recall had been expanded to include all infant formula products from the manufacturer in question. In several cases, recalled product returned by consumers was placed back on shelves,” according to the FDA letter.
Some of the deficiencies FDA and state and local health departments observed during recall checks at the retail level included:
- Lack of awareness of recalls: some retailers were not aware that a recall had been issued for products in their inventory.
- Lack of information to accurately identify all affected products: some retailers were uncertain about which lot numbers or product codes were subject to the recall, even though ByHeart recalled all of its product.
- Incomplete removal of recalled items: even when aware of the recall, some retailers did not remove all affected products from shelves and storage areas.
- Continued product distribution after recall notification: some retailers continued to receive and stock recalled products after being notified of the recall, and some accepted customer returns of recalled products and returned them to inventory for resale.
“While these failures to effectuate recalls mostly occurred at the retail level, they nonetheless signal systemic challenges that may exist across the industry,” the FDA said.
In the industry-wide letter, the FDA reminded businesses that they must have written recall plans. By law, the plans must include procedures that describe the steps to be taken, and assign responsibility for taking those steps. This includes:
- Direct consignee notification: Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food.
- Public notification: Notify the public about any hazard presented by the food when appropriate to protect public health.
- Effectiveness verification: Conduct effectiveness checks to verify that the recall is carried out.
- Product disposition: Appropriately dispose of recalled food, through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.
Warning letters sent to four major retailers
The publicly released warning letters sent to Albertsons, Kroger, Target and Walmart are partly redacted. Following are some details from the letters.
Target
Despite recall notifications, visits by regulators confirmed that recalled ByHeart Whole Nutrition Infant Formula remained available for purchase on shelves in at least (redacted) Target stores across 20 states well after the recall was initiated and subsequently expanded.
On Nov. 19, 2025, FDA held a call with Target officials to discuss the ineffectiveness of the recall. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Target stores nationwide.
Despite follow-up emails from the FDA on Nov. 20, 21, 24, and 26 and Dec. 1, 3, and 8, Target has not provided the agency with any information demonstrating that corrective actions to implement the recall have been put into place.
“The inadequacy of Target’s recall response was further demonstrated on Nov. 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 Nov. 16 to Nov. 22, 2025. This observation indicates not only Target’s failure to remove recalled infant formula from the store shelves, but the active promotion and discounted sale of recalled infant formula product implicated in an infant botulism outbreak, more than a (redacted) after Target was first made aware of ByHeart’s expanded recall,” according to the warning letter.
The full warning letter to Target can be found here.
Walmart
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 (redacted) Walmart store locations across 21 states from Nov. 12 to Nov. 26.
“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 regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification,” according to the warning letter.
On Nov. 18, FDA held a call with Walmart officials to discuss the ineffectiveness of its recall. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Walmart stores nationwide. Despite follow-up emails from the FDA on Nov. 20, 21, and 24 and Dec. 1, 3, and 8, Walmart has not provided FDA with any information demonstrating that corrective actions to implement the recall have been put in place.
The full warning letter to Walmart can be found here.
Kroger
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 (redacted) Kroger store locations across 10 states from Nov. 12, 2025, to Nov. 19, 2025.
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 regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.
On Nov. 19, the FDA held a call with Kroger officials to discuss the ineffectiveness of the recall within their stores. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Kroger stores nationwide.
Despite follow-up emails from the FDA on Nov. 20, 21, 24, and 25 and Dec. 1, 3, and 8, Kroger officials have not provided FDA with any information demonstrating that corrective actions to implement the recall have been put in place.
The full warning letter to Kroger can be found here.
Albertsons
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 (redacted) Albertsons store locations across 11 states from Nov. 12 to 19.
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 regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.
On Nov.20, 2025, FDA held a call with Albertsons officials to discuss the ineffectiveness of the recall within their stores. During this discussion, FDA requested information regarding actions the chain was prepared to implement to ensure recalled product was no longer available for purchase at Albertsons stores nationwide.
Despite follow-up emails from the FDA on Nov. 20 and 24, and Dec. 1 and 8, the chain officials have not provided FDA with any information demonstrating that corrective actions to implement this recall have been put in place.
The full warning letter to Albertsons can be found here.
