WARNING LETTER
The Kroger Company
MARCS-CMS 720464 —
December 12, 2025
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Ronald Sargent
Recipient Title
CEO
The Kroger Company
1014 Vine Street
Cincinnati
,
OH
45202-1100
United States
Issuing Office:
Human Foods Program
United States
December 12, 2025
WARNING LETTER
CMS #720464
Dear Mr. Sargent:
Beginning in November 2025, the U.S. Food and Drug Administration (FDA), in collaboration with the Centers for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, has been investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. As of December 3, 2025, CDC reported that 51 infants from 19 states have suspected or confirmed infant botulism.
1
Infants range from 16 to 264 days of age. Based on epidemiological evidence, CDC has determined that ByHeart Whole Nutrition Infant Formula was the source of this multistate infant botulism outbreak.
The presence of
Clostridium botulinum
in ByHeart Whole Nutrition Infant Formula, as evidenced by the recent foodborne outbreak, causes these products to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain an added poisonous or deleterious substance which may render them injurious to health.
On November 8, 2025, ByHeart Inc. (ByHeart) initiated a voluntary recall of
(b)(4)
lots of its ByHeart Whole Nutrition Infant Formula. The Kroger Company (Kroger) was notified on November 8, 2025, of this voluntary recall. On November 11, 2025, ByHeart expanded the recall to all ByHeart Whole Nutrition Infant Formula, including all unexpired lots of formula cans and single-serve “anywhere pack” sticks. As a consignee of the recalled products, Kroger was notified in writing on November 11, 2025, that the scope of the voluntary recall had expanded to include all ByHeart infant formula products. Despite these recall notifications, subsequent visits by regulators confirmed that recalled ByHeart Whole Nutrition Infant Formula remained available for purchase on shelves at
(b)(4)
Kroger stores, including Kroger’s, King Sooper’s, and Smith’s, across 10 states well after the recall was initiated and subsequently expanded. The receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof for pay or otherwise, is a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)]. You can find the FD&C Act and its implementing regulations through links on FDA’s home page at https://www.fda.gov.
Infant Botulism Investigation
Infants can develop infant botulism when a baby swallows
Clostridium botulinum
spores that grow in the immature gut and produce toxin. 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.
State and local public health officials are interviewing caregivers about the foods their infants consumed during the
(b)(4)
prior to illness onset. All 51 previously reported infant botulism cases were infants who had been fed ByHeart Whole Nutrition Infant Formula before becoming sick.
As part of its onsite inspections, FDA collected and is currently analyzing unopened product samples. This analysis is ongoing, and results will be shared as they become available. Additional testing by FDA, CDC, and state partners is also underway, with results expected in the coming weeks. Because detection of
Clostridium botulinum
in infant formula is scientifically complex, a negative test result does not rule out the presence of the bacteria in the product.
Receipt and Offer of Adulterated Foods
As noted above, FDA investigators and state and local partners reported that recalled ByHeart formula continued to be found on Kroger store shelves in multiple locations across multiple states. FDA and state partners have worked with retailers to ensure an effective recall and immediate removal of these products from all store shelves nationwide. All ByHeart infant formula products have been recalled, including all formula cans and single-serve “anywhere pack” sticks, and these products must not be available for sale in stores or online. The receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall. Once your firm has been made aware of a recall or potential safety issue, you should take action to immediately remove the affected product from distribution and sale, cease all further shipment or use, and implement all necessary measures to prevent further exposure to consumers or downstream distribution.
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)
Kroger store locations across 10 states from November 12, 2025, to November 19, 2025. This represents a period of
(b)(4)
days after Kroger was first notified of the initial recall and
(b)(4)
days after Kroger was notified of the recall expansion. 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 November 19, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Kroger stores. During this discussion, FDA requested information regarding actions you were 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 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 effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with the food you receive and offer for sale at your establishments. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe you are not in violation of the FD&C Act, include your reasoning and any supportive information for our consideration.
Please send your reply via email to: HFP-OCE-EmergingIssues@fda.hhs.gov, copying Katherine Arnold, Compliance Officer, at Katherine.Arnold@fda.hhs.gov. If you have any questions regarding any issues in this letter, please contact Katherine Arnold, Compliance Officer, via email at Katherine.Arnold@fda.hhs.gov. Please include CMS reference #720464 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Ann M. Oxenham, JD
Director
Office of Compliance and Enforcement
Human Foods Program
U.S. Food and Drug Administration
___________________
1
As of December 10, 2025, CDC broadened the definition for the outbreak investigation to include any infant with botulism who was exposed to ByHeart infant formula at any time since the product’s release in March 2022.
Content current as of:
12/15/2025
Regulated Product(s)
Food & Beverages