In a notice to the industry, FDA stated that inspectors "had checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. 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."
Here are the highlights for the Warning Letter to Kroger.
US Food and Drug Administration
https://content.govdelivery.com/accounts/USFDA/bulletins/4000713
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
U.S. Food and Drug Administration sent this bulletin at 12/15/2025 04:14 PM EST
The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations –infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.
In the weeks following the manufacturer's voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. 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. These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.
“Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food,” said FDA Commissioner Marty Makary, M.D., M.P.H.
When a food is recalled, every industry member along the supply chain plays an important role in carrying out the recall. Retailers play the especially crucial role in the last step of the supply chain by ensuring that recalled products are immediately removed and not available to consumers at their stores. The agency is particularly concerned with these retailers’ capability to quickly remove unsafe products from their store shelves and ensure it remains off shelves as required during a public health emergency. The FDA has asked these retailers to respond to the warning letters within 15 days stating the specific steps they have taken to address any violations and prevent the recurrence of violations, or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.
Today’s letter to industry builds on the FDA’s steps to advance the evolution of industry and government recall systems to transform how we work together to collect, analyze, and disseminate crucial recall information. Earlier this year, agency leadership called for increased attention to product recall communications from industry leaders involved in the manufacturing and distribution of infant formula, baby foods and foods intended for children. Additionally, under the efforts of Operation Stork Speed, the FDA continues to ensure that caregivers of infants and young children can have confidence that infant formula is safe and consistently available.
The FDA, in collaboration with the Centers for Disease Control and Prevention, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and state and local partners, has been investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. ByHeart Inc.'s voluntary recall began on Nov. 8, 2025, and was expanded on Nov. 11, 2025, to include all ByHeart Whole Nutrition Infant Formula products. The FDA has not received reports of recalled formula being found on store shelves since November 26, 2025.
- 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.
- 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
- On November 18, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Walmart 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 Walmart stores nationwide. 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.
Walmart, Albertsons and Target were issued similar letters with similar findings in failure to properly respond.
US Food and Drug Administration
https://content.govdelivery.com/accounts/USFDA/bulletins/4000713
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
U.S. Food and Drug Administration sent this bulletin at 12/15/2025 04:14 PM EST
The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country’s most vulnerable populations –infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.
In the weeks following the manufacturer's voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. 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. These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.
“Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation’s children from unsafe food,” said FDA Commissioner Marty Makary, M.D., M.P.H.
When a food is recalled, every industry member along the supply chain plays an important role in carrying out the recall. Retailers play the especially crucial role in the last step of the supply chain by ensuring that recalled products are immediately removed and not available to consumers at their stores. The agency is particularly concerned with these retailers’ capability to quickly remove unsafe products from their store shelves and ensure it remains off shelves as required during a public health emergency. The FDA has asked these retailers to respond to the warning letters within 15 days stating the specific steps they have taken to address any violations and prevent the recurrence of violations, or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.
Today’s letter to industry builds on the FDA’s steps to advance the evolution of industry and government recall systems to transform how we work together to collect, analyze, and disseminate crucial recall information. Earlier this year, agency leadership called for increased attention to product recall communications from industry leaders involved in the manufacturing and distribution of infant formula, baby foods and foods intended for children. Additionally, under the efforts of Operation Stork Speed, the FDA continues to ensure that caregivers of infants and young children can have confidence that infant formula is safe and consistently available.
The FDA, in collaboration with the Centers for Disease Control and Prevention, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and state and local partners, has been investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. ByHeart Inc.'s voluntary recall began on Nov. 8, 2025, and was expanded on Nov. 11, 2025, to include all ByHeart Whole Nutrition Infant Formula products. The FDA has not received reports of recalled formula being found on store shelves since November 26, 2025.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-720400-12122025
WARNING LETTER
Walmart, Inc.
MARCS-CMS 720400 — December 12, 2025
Recipient:
Doug McMillon
CEO
Walmart, Inc.
702 SW 8th Street, Ms 275
Bentonville, AR 72716-6299
United States
Issuing Office:
Human Foods Program
United States
December 12, 2025
WARNING LETTER
CMS #720400
Dear Mr. McMillon:
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 10, 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. Walmart was notified in writing 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, Walmart 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 in at least (b)(4) Walmart stores across 21 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 month 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 Walmart 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) 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. 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.
On November 18, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Walmart 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 Walmart stores nationwide. 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.
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, within15 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 #720400 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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kroger-company-720464-12122025
The Kroger Company
MARCS-CMS 720464 — December 12, 2025
Warning Letters
Recipient:
Ronald Sargent
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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/albertsons-companies-incorporated-720465-12122025
WARNING LETTER
The Albertsons Companies Incorporated
MARCS-CMS 720465 — December 12, 2025
Recipient:
Susan Morris
CEO
The Albertsons Companies Incorporated
M.S 10501 P.O. Box 29093
Phoenix, AZ 85038
United States
Issuing Office:
Human Foods Program
United States
December 12, 2025
WARNING LETTER
CMS #720465
Dear Ms. Morris:
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 10, 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. As a consignee of the recalled products, The Albertsons Companies Incorporated (Albertsons) was notified in writing 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. Albertsons 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) Albertsons stores, including Albertson’s, Star Market, Jewel-Osco, Acme, Safeway, and Shaw’s, across 11 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 month 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 Albertsons 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) Albertsons store locations across 11 states from November 12 to November 19, 2025. This represents a period of (b)(4) days after Albertsons was first notified of the initial recall and (b)(4) days after Albertsons was notified of the recall expansion. 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 November 20, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Albertsons 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 Albertsons stores nationwide. Despite follow-up emails from the 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 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 #720465 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
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/target-corporation-720399-12122025
WARNING LETTER
Target Corporation
MARCS-CMS 720399 — December 12, 2025
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Target Corporation
1000 Nicollet Mall
Minneapolis, MN 55403
United States
Issuing Office:
Human Foods Program
United States
December 12, 2025
WARNING LETTER
CMS #720399
Dear Mr. Cornell:
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 10, 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. As a consignee of the recalled products, Target was notified in writing 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. Target 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 in at least (b)(4) Target stores across 20 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 Target 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.
On November 19, 2025, Target advised FDA that it had placed an electronic block on the SKU for cans of recalled ByHeart infant formula on November 8, 2025, and single-serve “anywhere pack” sticks on November 11, 2025. However, during a recall audit check by an FDA investigator on November 17, 2025, our investigator was informed of a can of the recalled ByHeart infant formula being sold from a New Hampshire Target store on November 16, 2025. Additionally, 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) Target store locations across 20 states from November 12 to November 20, 2025. This represents a period of (b)(4) days after Target was first notified of the initial recall and (b)(4) days after Target was notified of the recall expansion. State and local partners reported several explanations offered by Target 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 Target 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 Target stores nationwide. Despite follow-up emails from the 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 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 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. 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 (b)(4) after Target was first made aware of ByHeart’s expanded recall.
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 #720399 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
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