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

NY Distributor Recalls Cooking Pot After FDA Determines It Contains Leachable Lead

Shata Traders Inc of Brooklyn, NY is recalling Chef Brand Milk Pan 24 cm, because it has the potential to be contaminated with significant levels of lead (Pb) which may leach into food. FDA collected the product samples from a retail store, and the product analysis found the products contain leachable lead that is harmful for human consumption.

The Chef Brand Milk Pan 24 cm product was distributed in NY, NJ, CT, MD, VA and MA areas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shata-traders-inc-recalls-chef-brand-milk-pan-24cm-because-possible-health-risk

SHATA TRADERS INC RECALLS CHEF BRAND MILK PAN 24cm BECAUSE OF POSSIBLE HEALTH RISK
Summary
Company Announcement Date:  November 19, 2025
FDA Publish Date:  November 19, 2025
Product Type:  Food & Beverages
Reason for Announcement: Product has the potential to be contaminated with significant levels of lead (Pb) which may leach into food
Company Name:  SHATA TRADERS INC
Brand Name:  Majestic Chef Pan
Product Description:  Milk Pan 24cm

Imported Strawberry Jam Recalled for Containing an Unapproved Color

Mangalm LLC of Newark, California, United States of America is recalling all /Tops Mixed Fruit Jam and Tops Strawberry Jam Products, because it contains carmoisine, (also know as FDA Red #10 and Azorubine.  It is designated E-122 in the EU) which is an unapproved color additive in the US.    The issue was discovered during an FDA inspection.  This product was imported from India, where the color is approved for use.

In an FDA background document:

Azorubine (carmoisine): This color was listed in 1939 as Ext. D&C Red No. 10 for

use in externally applied drugs and cosmetics and provisionally listed for these uses

in 1960, but was delisted in 1963 because no party was interested in supporting the

studies needed to establish safety. This color additive has never been approved by

FDA for use in food.

The color is approved for use in the EU, but must have a warning on the label indicating that  E122 could potentially increase symptoms of attention deficit hyperactivity disorder in children.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mangalm-llc-recalls-tops-mixed-fruit-jam-and-tops-strawberry-jam-product-because-possible-health
Mangalm LLC Recalls Tops Mixed Fruit Jam and Tops Strawberry Jam Product Because of Possible Health Risk
Summary
Company Announcement Date:  November 07, 2025
FDA Publish Date:   November 18, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Carmoisine
Company Name:  MANGALM LLC
Brand Name:  Tops
Product Description:  Mixed Fruit Jam and Strawberry Jam

Ohio Firm Recalls Mis-Formulated Ice Cream Bars with Allergen Concern

Jeni’s Splendid Ice Creams, Columbus, Ohio, is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy.  The recall was initiated after a crunch topping from a separate product was inadvertently introduced to this particular batch of Passion Fruit Dreamsicle Ice Cream Bars during manufacturing. The crunch topping contains wheat and soy, which is not declared on the packaging.

This is a case of mis-formulation with a post-process addition of the crunch topping containing the allergens. (The added allergens are bad enough, but nobody wants a crunch topping on their smooth-tasting passion fruit dreamsicle.  Just wrong.)

This product was distributed in grocery stores nationwide.  No illnesses or injuries have been reported to date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jenis-splendid-ice-cream-voluntarily-recalls-passion-fruit-dreamsicle-ice-cream-bars-due-undeclared
“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Summary
Company Announcement Date:  November 17, 2025
FDA Publish Date:  November 18, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - soy, wheat.
Company Name:  Jeni’s Splendid Ice Cream
Brand Name:  Jeni’s
Product Description:  Passion Fruit Dreamsicle Ice Cream Bars

Congress Restricts Use of THC in Food

Over the past few years, we have seen a number of food products containing THC, especially beverages and gummies.  These products came about from a loophole in the 2018 Farm Bill that "that allowed hemp-derived products containing tetrahydrocannabinol, or THC to be sold."

Congress decided to close this loophole and enacts stricter rules for hemp specifically a much lower limit for THC, the chemical that gives marijuana its psychological effects.  The bill will ban any products with more than 0.4 milligrams of THC.

USA TODAY
https://www.usatoday.com/story/news/nation/2025/11/15/hemp-loophole-familiar-products-could-be-banned/87249690007/
New law puts familiar drinks, creams and gummies in legal limbo
The provision closes a loophole that allowed hemp-derived products containing THC to be sold. Even products not marketed for their THC content may face legal problems.
Phaedra Trethan and Jeanine Santucci
November 15

The legislation to reopen the government also included strict new rules for hemp products that critics say threaten to outlaw mainstream drinks, creams, gummies, oils and vapes.

Oregon Creamery Recalls Cheese After FDA Testing Finds Listeria in Environment

Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes.  This recall is the result of an FDA environmental sample that identified the presence of Listeria monocytogenes in the processing area where this cheese was packaged. Finished product has not been tested positive for any contaminants.

The product was sold exclusively at Face Rock Flagship store in Bandon, Oregon.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/face-rock-creamery-llc-recalls-6oz-vampire-slayer-garlic-cheddar-because-possible-health-risk
Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
Summary
Company Announcement Date:  November 14, 2025
FDA Publish Date:  November 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Face Rock Creamery LLC
Brand Name:  Face Rock Creamery
Product Description:  Vampire Slayer Garlic Cheddar cheese

A Case of Toxic Squash Syndrome From Excessive Consumption of Gourd Juice

A Canadian woman became extremely ill suffering from toxic squash syndrome, or bitter bottle gourd poisoning" after consuming homemade juice from the calabash or bottle gourd.

After daily consumption of the juice, she was experiencing sudden weakness, nausea, vomiting, diarrhea and lower abdominal pain.  Medical tests "revealed that the woman's heart rate and breathing rate were high, and her blood pressure was initially high and then fell concerningly low. Her extremities were also unusually cool to the touch, indicating she had poor circulation. Meanwhile, one of the chambers of her heart was pumping very forcefully, and an echocardiogram suggested she was having other heart issues."  Internal investigation found her "stomach lining was inflamed and bleeding as a result of tissue damage, which was likely caused by poor oxygen delivery to the tissue."

The issue was the level of cucurbitacins.  An AI entry provides that these are "bitter-tasting chemical compounds found in plants of the Cucurbitaceae family (like cucumbers, melons, and squash), which protect wild plants from predators. While they can be toxic in high concentrations, especially in wild or improperly cultivated varieties, domesticated plants are bred to have low levels. Research indicates that cucurbitacins have potential medicinal uses, such as anti-inflammatory, antioxidant, and anticancer properties, but further research is needed to evaluate safety and efficacy. "

Why would she consume this?  Evidently, cucurbitacins have potential health benefits including ani-cancer, anti-inflammatory, liver health, hair growth, and anti-diabetic.  But this is 'potential' in that they are not fully understood, especially regarding dosage.  And controlled dosage can be difficult to manage when someone is just pureeing these at home in their food processor and consuming every day.  A good message to remember here is, "to live by the gourd, is to die by the gourd".


Live Science
https://www.livescience.com/health/food-diet/diagnostic-dilemma-a-womans-homemade-juice-led-to-life-threatening-toxic-squash-syndrome
Diagnostic dilemma: A woman's homemade juice led to life-threatening 'toxic squash syndrome'

Features

By Nicoletta Lanese published November 12, 2025

FDA Warning Letter to RTE Facility Highlights Inadequate Environmental Control That Resulted in Listeria Outbreak

The Warning Letter discussed here is a good example of not properly identifying and implementing a Sanitation Preventive Control in a RTE facility.  This facility had an ongoing Listeria contamination issue that had was not rooted out and eliminated.

FDA issued a Warning Letter to Fresh & Ready Foods LLC, San Fernando, CA, a division of Compass Foods, a manufacturer of ready-to-eat (RTE) sandwiches, salads, wraps, snack items, and entrees. The inspection was initiated as part of a multistate foodborne outbreak investigation of Listeria monocytogenes (L. monocytogenes) in which ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes.  

FDA environmental testing revealed that the clinical isolates match two (2) environmental swabs taken from production area during the FDA inspection of the facility (March 31 to April 15, 2025).

Did not consider environmental pathogens as a significant hazard warranting a preventive control, because of using prerequisite programs (SSOPs)  - "While the facility’s written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps, they determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."

Their approach was shown to be inadequate "as evidenced by the following analytical results, the SSOPs and GMPs are not adequate to ensure that [the] facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes

The positive findings included the food-contact surfaces of a:

- Conveyor belt and roller where in-process RTE sandwiches were placed.

- Slicer 3-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.

Interesting was that this was not the first time L. monocytogenes was found in the facility by FDA. "In 2017, FDA detected L. monocytogenes in (b)(4) environmental swabs, which included a swab collected from a direct food-contact surface taken from a mixing bowl.  The company indicated they would implement corrective actions at that time.  However, the "reoccurring presence of L. monocytogenes in [the] facility is significant in that it demonstrates [the] sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as to prevent contamination of food."

The company indicated they took corrective action after the FDA inspection, however, they did not provided sufficient verification to FDA that the measures taken were adequate.  The report states that the company has "not provided any additional information regarding your investigation on identifying the sources of L. monocytogenes to show that you have located and eradicated the harborage site(s), your updated food safety plan, your revised sanitation preventive control program, details regarding your revised environmental monitoring program to identify the target test microorganism, and the analytical methods you will be using. You also did not provide any of your associated cleaning and sanitation records to reflect your corrective actions, and you did not provide any training records that demonstrate your employees have been trained in proper sanitation."

Other issues

• Metal control - did not appropriately evaluate physical hazards such as metal, to determine whether it is a hazard requiring a preventive control in your RTE products.id not have adequate controls in place, as evidenced by missing metal lacing segments observed on Lines (b)(4) conveyor belts on March 31, 2025. Further, product manufactured on Line (b)(4) did not pass through a metal detector. Missing metal lacing segments is a repeat observation from our previous inspection of your facility.
• Supply chain program for RTE Ingredients - 'did not appropriately evaluate the hazard of biological pathogens associated with the ingredients as a known or reasonably foreseeable hazard requiring a preventive control, although there is a vendor approval program for ingredients. The facility produces ready-to-eat products containing ingredients with reasonably foreseeable biological hazards (specifically, chilled RTE produce) that do not undergo a validated (b)(4) step or other adequate lethality treatment within your facility to eliminate these identified hazards. Therefore, for those ingredients, one is required to establish and implement a supply chain program'

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/compass-group-usa-709592-09052025
WARNING LETTER
Compass Group USA
MARCS-CMS 709592 — September 05, 2025

First Reported Case of a Fatality Due to "Meat Allergy" Associated with Tick Bite

UVA Medical researchers are reporting the first death associated with someone have the 'meat allergy' acquired from getting bit by a Lone Star tick.

"A healthy 47-year-old man from New Jersey died abruptly four hours after consuming beef. The cause of his death had been a mystery until UVA Health’s Thomas Platts-Mills, MD, PhD, investigated. A world-renowned allergist, Platts-Mills discovered the allergy and remains the foremost expert on it."

"The allergy is caused by the bite of the Lone Star tick. Bites can sensitize people to alpha-gal, a sugar found in mammalian meat. People who become sensitized to the sugar can have allergic symptoms such as rash, nausea and vomiting after eating beef, pork or lamb. Researchers have feared that deadly anaphylaxis was possible in severe cases but had not confirmed a fatality from the allergy until now."

I thought this was very interesting.

"When asked about his history of tick bites, the man’s wife said he had none this past year but had 12 or 13 chigger bites around his ankles this summer. Platts-Mills realized that many “chigger bites” in the Eastern United States are actually bites from Lone Star tick larvae."

Eureka Alert
https://www.eurekalert.org/news-releases/1105793
1st death linked to ‘meat allergy’ spread by ticks
Peer-Reviewed Publication
University of Virginia Health System

University of Virginia School of Medicine researchers have identified the first death caused by what is commonly called the “meat allergy” being spread by ticks.

Australia - Improper Design of Labels on Bottles of Plant Milk Led to Botulism Case

In Australia, a food company was fined when product was labeled with a improperly designed label that led to a case of botulism.  Bottles of almond and oat milk had labels that read '“once opened, keep refrigerated and consume within 5 days” and should have stated, "Keep Refrigerated".  A customer bought the plant-based milk and then stored it on the shelf in kitchen rather than the refrigerator, and after a person drank the improperly stored milk-type product, they became ill with botulism poisoning.  That person spent 147 days in the ICU as their bodies overcame the effects of the neurotoxin. 

“The incorrect content of the label was originally prepared for use on another, shelf-stable Ultra High Temperature (UHT) product offering, and was then inadvertently copied across to the new product packaging,” Judge Payne said.

The fine was $200,000..which seems pretty light for a botulism case by US standards.

This is a good reminder how important label design and approval is for the safety of the product.  Allergens are often the issue with label design, but in this case, safe handling instructions.

https://www.news.com.au/lifestyle/health/health-problems/honest-oversight-almond-milk-label-error-lands-man-in-icu-for-147-days/news-story/e5316c0db9882d26f1b0a94932bc6adb
‘Honest oversight’: Almond milk label error lands man in ICU for 147 days
A man's 188-day hospital nightmare has led to heavy penalties for a milk company whose labelling error caused one of Australia's rarest poisoning cases.
Sarah Keoghan
November 6, 2025 - 2:16PM

Recall Notice of Prosecco Bottles Due to Potential for Exploding

On November 6, 2025, the U.S. Consumer Product Safety Commission announced a recall of  Kirkland Signature Valdobbiadene Prosecco DOCG due to exploding.   However the recall for the same product, including the same lot code dates, was posted in September. (https://pennstatefoodsafety.blogspot.com/2025/09/costco-issues-recall-for-prosecco-due.html).

So probably just a delay for the USCPSC getting this posted.

United States Consumer Product Safety Commission

https://www.cpsc.gov/Recalls/2026/F-F-Fine-Wines-Recalls-Kirkland-Signature-Valdobbiadene-Prosecco-DOCG-Bottles-sold-by-Costco-Due-to-Laceration-Hazard

F&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco DOCG Bottles sold by Costco Due to Laceration Hazard
Name of Product: Kirkland Signature Valdobbiadene Prosecco DOCG bottles

FDA and CDC Investigate Infant Botulism Outbreak - Company Recalls Baby Formula (FDA Update 11/11/2025)

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 15 infant botulism illnesses from 12 states (as of the 11/11/25 update).

A few important points to make

• Infant botulism occurs when infants, having yet to establish a stable colonization of their intestinal tract, consume food containing Clostridium botulinum spores.  These spores grow in anaerobic conditions in the intestines, and without a significant competing formula, multiply.  As they grow, they produce botulinum toxin which is absorbed into the bloodstream of the infant.  This toxin is a neurotoxin, which impacts neurotransmission to the autonomic nervous system.
• Infant formula, historically, has not been a known source for infant botulism.  However,  spores can be found in pasteurized milk as well as dried dairy products; this occurring generally through poor sanitary practices.  
• FDA stated that there are 84 cases reported since August 2025.  Only 15 of those cases have reported using this specific formula.  FDA states "According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants."
• "As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism"
• The company initially only recalled two lots of formula.  However, at FDA's request, the company expanded this recall to include all product.

Case Counts

Total Illnesses: 15
Hospitalizations: 15
Deaths: 0
Last Illness Onset: November 10, 2025
States with Cases: AZ, CA, IL, KY, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide

Symptoms

• Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
• If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
• Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.

Recall - ByHeart, Inc. initially recalled two lots of ByHeart Whole Nutrition Infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by the infants.  FDA requested and the company agreed to recall all product sold nationwide.

From FDA According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

NY Firm Recalls Uneviscerated Fish Due to Botulism Concern

African Food on Wheels Inc. of Bronx, NY is recalling 28 boxes of Product, because it is a dried, un-eviscerated (internal organs not removed) fish greater than 5 inches and length and has the potential to be contaminated with Clostridium botulinum.  The recall was initiated after FDA inspection and analysis revealed the product was not properly eviscerated.

Oven Dried Fish (SCOMBEROMORUS CAVALLA) was distributed to walk-in customers of African Food on Wheels Inc. located at 1376 Randall Avenue, Bronx, NY 10474 only


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/african-food-wheels-inc-recalls-oven-dried-fish-scomberomorus-cavalla-because-possible-health-risk
African Food on Wheels Inc. Recalls Oven Dried Fish (Scomberomorus Cavalla) Because of Possible Health Risk
Summary
Company Announcement Date:  November 05, 2025
FDA Publish Date:  November 06, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Clostridium botulinum
Company Name:  African Food on Wheels Inc.
Brand Name:  African Food on Wheels Inc.
Product Description:  Oven Dried Fish (Scomberomorus cavalla)

Ohio Firm Recalls English Muffins Due to Undeclared Milk

Blue Oven Bakery, Inc., Cincinnati, Ohio,  is issuing a voluntary recall on their english muffin for misbranding due to the milk allergen not being declared on the label.  These products have been produced since 04/24/25 with the last production date of 10/24/2025, so the label has been incorrect for 6 months.

There have been no reported illnesses.  Products were distributed in local markets.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-oven-bakery-inc-issues-voluntary-recall-due-undeclared-milk-allergens-their-english-muffin
Blue Oven Bakery, Inc. Issues a Voluntary Recall Due to Undeclared Milk Allergens in Their English Muffin
Summary
Company Announcement Date:  October 31, 2025
FDA Publish Date:  November 06, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Blue Oven Bakery, Inc.
Brand Name:  Blue Oven Bakery, Inc.
Product Description:  English muffin

SC Establishment Recalls Chicken and Beef Croquette Due to Undeclared Sesame

Brazilian Taste, a Lexington, S.C. establishment, is recalling approximately 4,120 pounds of chicken and beef croquettes due to misbranding and an undeclared allergen.  The problem was discovered when the Food and Drug Administration notified FSIS that bread crumb ingredients shared between FDA-regulated and FSIS-regulated products produced at the facility contained sesame that may not have been declared on the labels of the FSIS-regulated products.

These items were shipped to retail locations in Connecticut, Georgia, Massachusetts, North Carolina, South Carolina, and Texas, as well as nationwide through online sales.

https://www.fsis.usda.gov/recalls-alerts/brazilian-taste-recalls-frozen-chicken-and-beef-croquette-products-due-misbranding
Brazilian Taste Recalls Frozen Chicken and Beef Croquette Products Due to Misbranding and an Undeclared Allergen

FSIS Announcement

WASHINGTON, Nov. 4, 2025 – Brazilian Taste, a Lexington, S.C. establishment, is recalling approximately 4,120 pounds of chicken and beef croquettes due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains sesame, a known allergen, which is not declared on the product label.

Ice Cream Bars Recalled After Packaging Error Results in Undeclared Wheat

Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of its Häagen-Dazs Chocolate Dark Chocolate Mini Bars that may contain undeclared wheat.  The company is recalling this product because it may contain products that contain wheat in packaging that does not reveal the presence of wheat on the label. Although the company's investigation is ongoing, they believe products containing wheat were repacked into the incorrect packaging at the beginning of a production run.

The affected product was shipped to two retail customers, Kroger and Giant Eagle, in the following states:

Kroger: (AL, AK, AZ, AR, CA, CO, GA, ID, IL, IN, KS, KY, MI, MS, MO, MT, NE, NV, NM, OH, OR, SC, TN, UT, VA, WA, WV, WI, WY)

Giant Eagle: (IN, MD, OH, PA, WV)

No illnesses or injuries have been reported to date.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dreyers-grand-ice-cream-inc-issues-allergy-alert-undeclared-wheat-haagen-dazs-chocolate-dark
Dreyer's Grand Ice Cream, Inc. Issues Allergy Alert on Undeclared Wheat in Haagen-Dazs Chocolate Dark Chocolate Mini Bars in 6 Count Pack
Summary
Company Announcement Date:  November 03, 2025
FDA Publish Date:  November 04, 2025
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared wheat
Company Name:  Dreyer’s Grand Ice Cream, Inc.
Brand Name:  Haagen-Dazs
Product Description:  Ice Cream Bars

CT Firm Recalls Tomato Sauces Processed Without Compliance to Federal Canning Regulations

First and Last Bakery, LLC of Hartford, CT, is recalling the Tomato-based sauces because they did not process the product under federal guidelines for canning foods.  The potential risk is growth and toxin formation by Clostridium botulinum, the causative agent of  botulism.

"The products were manufactured without an approved scheduled process or otherwise evaluated to determine if the process is adequate. Failure to appropriately process acidified or low-acid canned foods can result in Clostridium botulinum toxin formation."

The products were distributed in Connecticut and Massachusetts through Big Y and Stop & Shop retail stores, starting on September 22, 2025, and continuing through 09/22/2025.  They were also sold online.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/first-and-last-bakery-llc-recalls-first-and-last-brand-tomato-sauce-products-because-possible-health
First and Last Bakery, LLC Recalls First and Last Brand Tomato Sauce Products Because Of Possible Health Risk
Summary
Company Announcement Date:  October 31, 2025
FDA Publish Date:  November 03, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential for Clostridium botulinum hazard as the product is manufactured without an approved schedule
Company Name:  First and Last Bakery LLC
Brand Name:  First & Last
Product Description: Marinara Sauce, Puttanesca Sauce, and Meat Flavored Pasta Sauce

Texas Distributor Recalls Peach Salsa Linked to Peaches Recalled Due to Listeria

Supreme LLC., Farmer's Branch, TX,  (dba Supreme Produce) is recalling peach salsa after the recall initiated by its supplier, Moonlight Companies, which had recalled white and yellow flesh peaches on October 29th due to potential contamination with Listeria monocytogenes.

This is one confusing recall notice.  It seems to discuss whole peaches, but identifies the peach salsa as the specific product being recalled.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supreme-produce-llc-voluntarily-recalls-moonlight-peaches-because-possible-health-risk
Supreme Produce LLC Voluntarily Recalls Moonlight Peaches Because of Possible Health Risk
Summary
Company Announcement Date: October 30, 2025
FDA Publish Date:  November 03, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes.
Company Name:  Supreme Produce
Brand Name:  Supreme Produce
Product Description:  Peach Salsa