FDA and CDC Issue Update on Infant Botulism Cases Linked to Infant Formula (11/26/25)

FDA and CDC released an update on the ongoing botulism outbreak in infants.  "As of November 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 17 states.  All 37 infants were hospitalized. No deaths have been reported to date. For 35 infants with age and sex information available, they range in age from 16 to 264 days and 15 (43%) are female."

Case Counts
Total Illnesses: 37 (6 New)
Hospitalizations: 37 (6 New)
Deaths: 0
Last Illness Onset: November 19, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally

"FDA’s investigation, including onsite inspections, is ongoing to determine the point of contamination. FDA is releasing the FDA Establishment Inspection Reports (EIRs) and FDA Form 483s, Inspectional Observations from completed inspections previously conducted between 2022 and March 2025 at ByHeart facilities. ByHeart, Inc. is the parent company of three Blendhouse manufacturing facilities in Allerton, Iowa; Portland, Oregon; and Reading, Pennsylvania."

1. Blendhouse Allerton: the facility was last inspected in February 2025 and classified Voluntary Action Indicated (VAI), which cited GMP deficiencies - https://www.fda.gov/media/189825/download
2. Blendhouse Portland: the facility was last inspected in March 2025 and classified No Action Indicated (NAI) - https://www.fda.gov/media/189824/download
3. Blendhouse Reading: the facility was last inspected in January 2024 and classified Official Action Indicated (OAI). This facility has not been in operation since September 2023. - https://www.fda.gov/media/189831/download

In Food Safety Magazine (Nov 25, 2025) points out an important items - that the California Department of Health has noticed a broader spike of infant botulism cases.

"A spike in infant botulism cases was first noticed by CDPH’s Infant Botulism Treatment and Prevention Program (IBTPP), which operates the only global source of infant botulism treatment worldwide. According to CDPH, this spike has grown from the originally reported 84 cases to now include 107 cases of infant botulism, occurring between August 1, 2025 and November 19, 2025. Not all infants treated for infant botulism during this spike have confirmed exposure to ByHeart infant formula.  Typically, less than 200 cases of infant botulism are reported in the U.S. each year."

It also stated that some of the cases that have been linked to the suspect product came earlier, between November 2024 and June, 2025).  Linking all of these cases may be difficult.  "It will be more difficult to definitively link cases that happened before August 1 to the current outbreak, due to the amount of time that has passed and it being unlikely that parents would have recorded product lot numbers or kept empty cans of formula."

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.
Product:
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks.

Milk Recalled from Iowa Processing Facility for Potential to Contain Cleaning Agents

Prairie Farms is announcing a recall of select Prairie Farms Gallon Fat Free Milk produced at its Dubuque, Iowa facility and distributed to Woodman’s stores in Illinois and Wisconsin. Some of the product may contain food-grade cleaning agents, which may cause illness if consumed. Only a specific segment of the DEC08 production run was impacted. The affected product was processed between 17:51 and 21:23, representing a portion of that day’s production.

"On November 24, Prairie Farms was made aware of a potential quality issue. An investigation was immediately initiated, and based on that investigation, affected product was removed from stores and a recall was initiated. Approximately 320 gallons were sold before the issue was discovered."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prairie-farms-announces-recall-prairie-farms-gallon-fat-free-milk
Prairie Farms Announces Recall of Prairie Farms Gallon Fat Free Milk
Summary
Company Announcement Date:  November 25, 2025
FDA Publish Date:  November 26, 2025
Product Type:  Food & Beverages 
Reason for Announcement:  May contain food-grade cleaning agents
Company Name:  Prairie Farms
Brand Name:  Prairie Farms
Product Description:  Fat Free Milk

Romano Cheese Recalled After Supplier Identifies Listeria Concern

The Ambriola Company is recalling select cheese products after routine testing confirmed the presence of Listeria monocytogenes. Ambriola has suspended production and distribution of affected products as the Company conducts a thorough review of all sanitation and food safety procedures

An earlier recall from Supreme Service Solutions for Boar's Head branded cheese from this supplier had already been posted.

Wegmans Food Markets is recalling this product, Locatelli Grated Pecorino Romano Cheese with Wegmans’ scale labels due to the potential presence of Listeria monocytogenes. This product was sold at Wegmans stores in Connecticut, Delaware, Maryland, Massachusetts, North Carolina, New Jersey, New York, Pennsylvania, Virginia, and Washington, D.C.

between November 14 and November 24, 2025.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ambriola-company-issues-recall-cheese-products-because-listeria-health-risk
The Ambriola Company Issues Recall of Cheese Products Because of Listeria Health Risk
Summary
Company Announcement Date: November 25, 2025
FDA Publish Date:  November 26, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  The Ambriola Company
Brand Name:  Ambriola, Locatelli, Member’s Mark, Pinna, and Boar’s Head
Product Description:  Cheese
Company Announcement

CDC MMWR Report - 2024 E. coli STEC Outbreak Linked to Walnuts

In CDC's MMWR, an article discussing the 2024 E. coli STEC outbreak linked to walnuts where 13 cases were reported.  It is interesting in that this is the first reported case of walnuts being the source of an E. coli STEC outbreak.   

"All walnuts eaten by patients were specified during an interview or documented in purchase records at food co-ops or natural food stores as being “organic.” Ten patients purchased walnuts from bulk or self-service bins. Leftover walnuts from four patient homes (two each in California and Washington) were tested; one sample was positive for the gene encoding Shiga toxin by real-time polymerase chain reaction testing."

"On April 27, 2024, the walnut processor recalled the two lots of walnut halves and pieces identified by the traceback investigation. On April 30, CDC and FDA advised the public to avoid consuming the recalled walnuts and provided a complete list of store names and locations that had received affected walnuts. The investigation was closed on June 25, 2024, when no additional illnesses meeting the case definition had been identified for several weeks, the environmental assessment had concluded, and the investigation team was confident that the contaminated walnuts were no longer available for purchase after the recall. Rapid detection, investigation, and product recall likely prevented additional illnesses from a product with a long shelf life. This outbreak demonstrates that walnuts can be contaminated with STEC and cause illness although the route of STEC contamination was not identified in this investigation. Producers of tree nuts should take steps to minimize the risk for bacterial contamination from the environment via multiple potential sources (e.g., water, soil, adjacent land use, and production environment) throughout growing, ground harvesting, hulling, shelling, and packing (4,5)"

However, the report does not provide much information on how the walnuts may have become contaminated.   Walnut processing is an interesting, highly mechanized process, so I guess you can see how contamination may have been carried through the process in a broken shell?  To what degree does the product being organic factor into this...not sure if sanitizers used in wash water of the nuts are any less effective?

As stated in the report, companies should consider E. coli STEC as a contaminant along with pathogens like Salmonella.

https://www.cdc.gov/mmwr/volumes/74/wr/mm7438a2.htm?s_cid=OS_mm7438a2_w
Notes from the Field: Outbreak of Escherichia coli O157:H7 Infections Linked to Organic Walnuts — Washington and California, 2024
Weekly / November 27, 2025 / 74(38);597–598
Angelica L. Barrall, PhD1,2; Laurie Stewart, MS3; Jeffrey Higa, MPH4; Erin Jenkins, MPH5; Brooke Whitney, PhD5; Brandon Adcock4; Anna Pickett3; Bethan Swift, DPhil1,6; Peiman Aminabadi, DVM7; Kenneth Zamora4; Susan Shelton3; Karen P. Neil, MD2; Laura Gieraltowski, PhD2 (View author affiliations)

NJ Firm Recalls Uneviscerated Fish Due to C. botulinum Risk

Mamtakim Inc, located of Elizabeth, NJ 07201, is recalling Item # LL0320 DRIED WHOLE SMELTS SALTED (KORUSHKA), 5.29 oz (150 g) / 20 – 1 box, because this product consists of dried, un eviscerated fish longer than 5 inches, which is a risk for Clostridium botulinum growth and toxin formation.  The recall was initiated after an FDA inspection and analysis determined that the fish had not been properly eviscerated, which can allow Clostridium botulinum to grow.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mamtakim-inc-recalls-dried-whole-smelts-salted-korushka-because-possible-health-risk
MAMTAKIM Inc Recalls Dried Whole Smelts Salted (KORUSHKA) Because of Possible Health Risk
Summary
Company Announcement Date:  November 25, 2025
FDA Publish Date:  November 25, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Clostridium botulinum.
Company Name:  Mamtakim, Inc.
Brand Name:  Belevini
Product Description:  Dried Whole Salted Smelt, Mullet, Goby

Deli Products Recalled After Cheese Supplier Recalls Cheese for Listeria

Supreme Service Solutions LLC. (dba Supreme Deli) is assisting in a recall for items purchased from Boar’s Head Brand’s supplier of pecorino romano cheese. Ambriola Company, has issued a recall for select SKUs of pecorino romano cheese products, including two products they produce under the Boar’s Head Brand label, due to the potential presence of Listeria monocytogenes.  The potential contamination was discovered by Ambriola Company who initiated their recall after the US Food and Drug Administration (“FDA”) notified them that the Pecorino Romano Cheese described above were associated with reported Ambriola Company has issued a Class I recall for the items due to potential adulteration with Listeria.

Ambriola Company has issued a Class I recall for the items (see table above) due to potential adulteration with Listeria monocytogenes.  In addition, and in an abundance of caution, Boar’s Head has made the decision to withdraw all products Ambriola Company produces for Boar’s Head. This includes the following additional products NOT affected by the recall:

Unfortunate that after Boar's Head Listeria outbreak earlier this year, that the company's brand name is  now involved in a recall because of their cheese supplier.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supreme-deli-llc-voluntarily-recalls-boars-head-pecorino-romano-cheese-because-possible-health-risk
Supreme Deli LLC Voluntarily Recalls Boar’s Head Pecorino Romano Cheese Because of Possible Health Risk
Summary
Company Announcement Date:  November 24, 2025
FDA Publish Date:  November 24, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Due to the potential presence of Listeria monocytogenes
Company Name:  Supreme Service Solutions, LLC.
Brand Name:  Boar’s Head
Product Description:  Chicken Caesar Salad and Wrap

FDA and CDC Provide Update on Infant Botulism Cases Linked to Infant Formula (Nov 20, 2025)

FDA and CDC provided an update (Nov 20, 2025) on the investigation into infant botulism cases liked to infant formula.   As of November 20, 2025, there had been 31 reported cases with no reported deaths.

One issue of concern as stated in the FDA update was that product was still available for sale by some retailers.  Another concern was that some product was being sold online and shipped overseas where these people may not have been made aware.

The organism was found in the infant formula although its source had not yet been identified.  "As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third party laboratory analysis of some of these samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak. ByHeart states that it will continue to investigate these findings and perform ongoing testing to identify the source of contamination."

Case Counts
Total Illnesses: 31 (8 New)
Hospitalizations: 31 (8 New)
Deaths: 0
Last Illness Onset: November 13, 2025
States with Cases: AZ, CA, ID, IL, KY, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide (including Guam and Puerto Rico)

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use recalled ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.

Product:
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks.
ByHeart infant formula products makes up approximately 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

FDA and CDC Investigation into August Salmonella Outbreak Linked to Eggs Is Over

The FDA and CDC investigated illnesses in a multistate outbreak of Salmonella Enteritidis infections linked to large, brown, cage-free "sunshine/omega-3 golden” yolk eggs sourced from Country Eggs, LLC, of Lucerne Valley, CA.   The first notice was issued in August of 2025 and it is now reported that the outbreak is over and the investigation has been completed.  There were 105 reported cases from 14 states.  WGS analysis of environmental samples from the site matched the outbreak strains. 

"FDA initiated an inspection at Country Eggs, LLC, that included environmental sample collection. Of the samples collected, three of the environmental samples tested positive for Salmonella that matched the strain causing illnesses in this outbreak by whole genome sequencing (WGS) analysis."

"Based on epidemiological information collected by CDC, a total of 105 people infected with the outbreak strain of Salmonella have been reported from 14 states. Illnesses started on dates ranging from January 7, 2025, to August 14, 2025. 38 of 42 ill persons with information available reported exposure to eggs or an egg-containing dish before becoming ill. There have been 19 hospitalizations, and no deaths have been reported."

Case Counts
Total Illnesses: 105
Hospitalizations: 19
Deaths: 0
Last Illness Onset: August 14, 2025
States with Cases: AZ, CA, FL, GA, HI, IA, MN, NC, NE, NM, NV, NY, PA, WA
Product Distribution: CA, NV
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-eggs-august-2025
Outbreak Investigation of Salmonella: Eggs (August 2025)
Outbreak is over. FDA’s outbreak investigation is complete.

Product:
On August 27, 2025, Country Eggs, LLC recalled large, brown, cage-free "sunshine/omega-3 golden” yolk eggs under the brand names Nagatoshi Produce, Misuho, Nijiya Markets, and Country Eggs.

This outbreak appears to be over. Product causing illness is no longer on the market.

NY Firm Recalls Dessert Buns For Improperly Designed Label Missing Milk Allergen

Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted butter listed in the ingredient statement.  The issue was identified during an internal product review. The recall was initiated after it was discovered that packaging did not declare milk in the allergen statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s label review process.

The recalled products were distributed to Asian grocery stores between April 2, 2025 and November 14, 2025 in the following states:  AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prime-food-processing-llc-issues-allergy-alert-undeclared-milk-lava-bun-w-salted-egg-yolk-and-lava
PRIME FOOD PROCESSING LLC ISSUES ALLERGY ALERT ON UNDECLARED (MILK) IN LAVA BUN W/ SALTED EGG YOLK AND LAVA BUN WITH GREEN TEA FLAVOR
Summary
Company Announcement Date:  November 20, 2025
FDA Publish Date:  November 20, 2025
Product Type:  Food & Beverages  Allergens
Reason for Announcement:  Undeclared milk allergen
Company Name:  Prime Food Processing LLC
Brand Name:  Prime Food
Product Description:  Lava Buns