FDA Provides Update on Infant Botulism Outbreak (12/3/25)

FDA provided an update on the multistate outbreak of infant botulism. 

• "Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country".  
• "As of December 3, 2025, a total of 39 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 18 states. "
• "Illnesses started on dates ranging from August 9 to November 19, 2025. All 39 infants were hospitalized. No deaths have been reported to date."
• "FDA continues to receive reports that recalled formula is still being found on store shelves at Walmart, Target, Kroger, Acme, and Shaw’s, despite the ongoing recall of all ByHeart infant formula products. FDA continues to work with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country"
• Sampling - 6 samples of product have been found to be positive for Clostridium botulinum Type A.

Case Counts
Total Illnesses: 39 (2 New)
Hospitalizations: 39 (2 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, VA, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally


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 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 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.

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.

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.

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

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.

Rice Products Recalled Due to the Potential for Small Stones in Product

Ben's Original is initiating a voluntary recall in the United States on a limited number of Ben's Original Long Grain White, Whole Grain Brown, and Long Grain & Wild Ready Rice products due to the possible presence of small, naturally occurring stones originating from the rice farm.  This is an isolated issue limited to these batches— no other Ben's Original™ products are affected.

In commercial rice operations, stones are removed through specific equipment that separates based on density.  Generally this is done with the use of forced air that causes the lighter rice grains to be separated from heavier rocks.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bens-originaltm-issues-voluntary-recall-select-bens-original-long-grain-white-whole-grain-brown-and
Ben’s Original™ Issues Voluntary Recall of Select Ben's Original Long Grain White, Whole Grain Brown, and Long Grain & Wild Ready Rice Products Due to Possible Presence of Small Stones from Farm
Summary
Company Announcement Date:  October 10, 2025
FDA Publish Date:  October 14, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foreign Body Contaminant – Small Stones
Company Name:  Ben’s Original
Brand Name:  Ben’s Original

CT Processor of RTE Produce Cited for Listeria Control Violations

FDA issued a Warning Letter to Gracie's Kitchens, Inc. of New Haven, CT, a  manufacturer of ready-to-eat (RTE) fresh cut fruits and vegetables, sauces, and non-RTE (NRTE) vegetable products. 

FDA "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes)" in the facility.

Lack of Listeria Control 

• As evidenced by recurring environmental findings of L. monocytogenes in the facility, the company did not implement sanitation controls adequate to ensure that the facility was maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes,
•  The positive swabs were recovered, while the facility was processing RTE vegetables and fruit, from food contact surfaces in the main production area, including:
• A cutting board on the surface of Table (b)(4) holding a tray of raw chicken on one side and packed potatoes on the other side.
• The interior of a grey bin next to Table (b)(4) holding artichokes in the process of being stuffed.
• Reoccurrence - This was not the first time that L. monocytogenes was found in environmental swabs collected in the facility. On April 9, 2024, FDA detected L. monocytogenes in (b)(4) environmental swab from the left side of the floor surface area in the cooler.
• In reviewing the facility’s environmental monitoring program, FDA noted that the company's own environmental monitoring program has repeatedly found L. monocytogenes and Listeria spp.  A review of the laboratory reports dated May 7, May 9, May 11, May 18, May 20, and May 22, 2024, found Listeria spp. was recovered from multiple non-food-contact surfaces, including but not limited to the concrete floor patch by table (b)(4) sampled on May 8, May 14, and May 16, 2024. On May 16, 2024, the concrete patch by table (b)(4) was also positive for L. monocytogenes.
• Not following the environmental monitoring procedure - the company did not perform any vector testing, intensified cleaning, and sanitizing, nor did it conduct additional activities to identify sources and routes of contamination. Furthermore, FDA's review of the laboratory reports found environmental swabs collected from the wheels on green cart (b)(4) on May 2, 2024, and green cart (b)(4) on May 8, 2024, were positive for Listeria spp. These carts move freely from the main processing area to other areas of the facility, including the cooler and loading dock. The company did not document this activity or any other follow-up activities. Retesting and vector testing were not conducted, and no other documentation was provided to show whether corrective actions were implemented.

Allergen Control 

• Failed to identify undeclared allergens due to incorrect labeling as a food safety hazard requiring a preventive control. The facility handles and manufactures stuffed vegetable products, including stuffed artichokes and stuffed mushrooms containing the following allergens: fish (pollack, whiting), wheat, sesame, crustacean shellfish (crab), egg, soy, and milk. Undeclared allergens are a known or reasonably foreseeable hazard.  
• Allergen preventive control program did not specify how sequencing will be accomplished or what safeguards will be in place to assure allergen ingredients are stored separately. The program does not contain written monitoring procedures including frequency, corrective actions, and verification procedures. Furthermore, there were no records documenting activities performed.

Supply Chain 

• The hazard analysis identifies biological hazards at the (b)(4) step as reasonably likely hazards to occur and identifies a supplier approval program, “(b)(4),” Rev 03/03/19 to control that hazard. Under the “(b)(4) section of your “(b)(4)” it states, “(b)(4).” The written procedure does not specifically require review of annual onsite audit results to ensure control of vegetative bacterial pathogens (e.g., Salmonella and L. monocytogenes) in raw materials or other ingredients via the supply-chain program.

GMP issues were observed, many of which can be real issues for the spread of Listeria within an operation.  These include:

• Rinsing tables (b)(4) where water routinely splashed off the walls on to the cutting tables (food contact surface). FDA isolated L. monocytogenes from a swab collected from the cutting board on table (b)(4), which was used in the processing of RTE peppers and onions and NRTE potatoes.
• Spraying the floors after cleaning,where water was splashing off the floor on to the legs and frame of the cutting board tables and misting on to the surface of the cutting boards. 
• Spraying the floor mats, where water was splashing off the mats, floor, and drain onto equipment, including but not limited to the Urschel chopper and finished product packaging that are used to package both RTE and NRTE finished products. The Urschel chopper was later used to process NRTE butternut squash.
• High pressure water hoses were routinely placed on the floor and employees conducting sanitation were observed handling these hoses that were touching the floor with their gloved hands. After handling the hoses, the employees touched food surfaces including cutting boards and the middle conveyor belt with their gloved hands. The employees did not change their gloves or wash their hands. 
• During cleaning of white totes, water was observed splashing off the floor on to the bin stands and metal racks. The bin stands are used to hold totes of RTE produce and the metal racks were used to hold trays of RTE products.
• The plant floor in the middle room, at the doorways, and inside the walk-in cooler area is rough with exposed concrete, and pooling water was observed. There was an apparent red visible liquid (appeared to be liquid from raw meat products) observed pooling on the floor at the doorway between the middle and main processing. This is a high foot traffic area with employees, pallet jacks, and rolling carts moving freely between the front to the rear (b)(4) dumpster area and walk-in cooler during processing of RTE vegetables and fruits.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gracies-kitchens-inc-701613-09032025
Gracie's Kitchens, Inc.
MARCS-CMS 701613 — September 03, 2025

Listeria Outbreak with 20 cases and 4 Deaths Linked to RTE Pasta

The FDA, USDA and CDC with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to prepared meals. There have been 20 cases with 19 being hospitalized and 4 deaths.

Case Counts
Total Illnesses: 20
Hospitalizations: 19
Deaths: 4
Last Illness Onset: September 11, 2025
States with Cases: CA, FL, IL, IN, LA, MI, MN, MO, NC, NV, OH, SC, TX, UT, VA
Product Distribution: Nationwide

The pasta supplier, Nate’s Fine Foods of Roseville, CA, does not sell affected products direct to retail. On September 25, 2025, the supplier of the affected pasta, recalled certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes. FreshRealm recalled linguine and meatball product which was under the Marketside (Walmart) brand. Additional product recalled include Marketside Grilled Chicken Alfredo with Fettuccine 12.3 oz – best-by date of June 26, 2025, or prior; Marketside Grilled Chicken Alfredo with Fettuccine 32.8 oz – best-by date of June 27, 2025, or prior; Home Chef Chicken Fettuccine Alfredo 12.5 oz – best-by date of June 19, 2025, or prior; and TRADER JOE’S CAJUN STYLE BLACKENED CHICKEN BREAST FETTUCINE ALFREDO” with “best if used by” dates 9/20/2025, 9/24/2025, or 9/27/2025.

The contaminated ingredient was found in response to the investigation, "FreshRealm Inc., began testing individual ingredients used to produce their Marketside-brand linguine with beef meatballs & marinara sauce meal, and the company’s ingredient testing of linguine pasta samples were confirmed positive for Listeria monocytogenes by FreshRealm’s contracted lab. On September 27, 2025, FDA was informed by FreshRealm that whole genome sequencing performed by the company’s contracted lab confirmed the linguine sample is positive for the same strain of Listeria that was detected in the company’s chicken alfredo meals, which were recalled on June 17, 2025. It is also the same strain of Listeria that is linked to causing illnesses in this outbreak."

Being a USDA regulated facility, the company is not subject to Preventive Controls, and with that, does not have to have a Supply Chain Preventive Control, which would be a must for the type of product (heat and serve which is ready-to-eat).   As this is the case, the processor would have recognized Listeria as hazard on the incoming RTE pasta (as well as other ingredients) and would have ensure that the supplier had an active Listeria Control Program.  

As for the pasta supplier, they do operate under Preventive Controls and would definitely need to have a Sanitation Preventive Control to ensure that recontamination does not occur after pasta preparation.   Pasta preparation require boiling pasta which would eliminate Listeria, however, it can be recontaminated in the post-process environment.  With a Sanitation Preventive Control, monitoring and verification steps would be present for ensuring the food contact surfaces and the overall post-process environment were free from Listeria.   This was not the case with this facility however.

Unfortunately, the continued push for RTE meals requires more attention by companies producing that product.  If this had been a product to be cooked, the likelihood of illnesses would have been reduced or eliminated.   This however, would not eliminate the needs for Listeria controls because one would still need to be concerned about undercooking.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-prepared-pasta-meals-june-2025
Outbreak Investigation of Listeria monocytogenes: Prepared Pasta Meals (June 2025)
Do not eat or serve certain meals containing pre-cooked pasta. FDA’s investigation is ongoing.

Products:

On September 25, 2025, the supplier of the affected pasta, recalled certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes.

CDC Reports Salmonella Outbreak Linked to Home Delivery Meal. Raises Concerns for Risk Associated with RTE Meals by Mail

CDC reported a Salmonella outbreak linked to home delivered meals.   There have been 16 reported cases of Salmonella infection reported from 10 different states.  The product is sold through an online-based company, Metabolic Meals, whose location is not apparent.   This is a ready-to-eat, reheat only, type of food, which means the producer is fully preparing the product.  There are 3 date codes involved, but no recall was issued due to the fact that all product is shipped immediately and the shelf-life is short.

There have been an increasing number of these companies that market these 'chef' prepared, home delivered meals.   This outbreak should raise questions as to the safety of this food and the operations that prepare it.   Unlike a restaurant or store that you can actually see or inspections that you can obtain, people do not have much information on these operations.  

Looking at the website, I was not able to determine where the food is actually made.  Was it made in some shotgun shack?  Who is inspecting these operations?  Perhaps some municipality where the inspectors are unaware of issues of RTE home delivered meals?  Home delivered often skate the boundary between local and Federal inspection.

It is important to point out that home-delivered meals, especially RTE refrigerated meals, have some risks that need to be controlled.  First is proper preparation where cooking and cooling steps must be adequately addressed.  But then there is the delivery component, where safeguards must be in place to prevent temperature abuse during transport. 

There is little information outside of the website to make valid decisions.  Slick websites with appealing food are not sufficient and can be misleading.  I was able to find a physical location for the facility in St. Louis MO.  It is a USDA inspected facility.

https://www.cdc.gov/salmonella/outbreaks/homedeliverymeals-09-25/index.html
Salmonella Outbreak Linked to Home Delivery Meals
Investigation status: Open
Recall issued: No

CDC and public health officials in several states are investigating a multistate outbreak of Salmonella infections linked to certain home delivery meals made by Metabolic Meals. Do not eat affected Metabolic Meals products while the investigation is ongoing. Check your refrigerator and freezer for these products and throw them away or contact the company.

Affected food - Metabolic Meals home delivery service products:
Select meals delivered during the week of July 28, 2025
Four Cheese Tortellini with Pesto Sauce and Grilled Chicken
Lot Code: 25199
Best By: 08/07/2025
Low Carb Chicken Teriyaki and Vegetables
Lot Code: 25202
Best By: 08/05/2025
Black Garlic & Ranch Chicken Tenders with Roasted Vegetables
Lot Code: 25205
Best By: 08/08/2025
Sliced Top Sirloin with Roasted Peanut Sauce and Summer Vegetables
Lot Code: 25203
Best By: 08/06/2025
Additional meal lot codes include: 25199, 25202, 25203, 25204, 25205

FDA to Revoke 52 Food Product SOIs (Standard of Identity)

FDA announced that it plans to revoke 52 obsolete food standards, or Standards of Identity (SOI) of the more than 250 that exist.  According to FDA, "The FDA’s Standards of Identity efforts have helped ensure uniformity, boost consumer confidence and prevent food fraud. But many of these standards have outlived their usefulness and may even stifle innovation in making food easier to produce or providing consumers healthier choices."

The list of items are provided below.  The only one I saw of interest to me was removal of the standard for raw, lightly breaded shrimp.  While it was removed, the standard for raw breaded shrimp remains.  The difference is that with lightly breaded shrimp, the shrimp constitutes 65% of the product whereas with raw breaded shrimp, the standard is that the product is comprised of at least 50% shrimp with the rest breading.  

https://www.fda.gov/news-events/press-announcements/fda-revoke-52-obsolete-standards-identity-food-products
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
Today’s action builds on Trump Administration’s deregulatory initiative.

For Immediate Release:
July 16, 2025

The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products and other foods.

Pistachio Cacao Cream with Kadayif Recalled After Product Tests Positive for Salmonella, Linked to Outbreak

World Market of Alameda, CA is recalling EMEK SPREAD PISTACHIO CACAO CREAM WITH KADAYIF, 9.7oz, Best Before: April 01, 2027, Batch Number: 250401 due to a potential contamination of Salmonella.  The firm initiated the recall after samples of the product were tested by the FDA and the products tested positive for Salmonella.

The product is sold primarily in World Market retail stores located in the States of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, OK, PA, SC, SD, TN, TX, VA, WA & WI.

As of June 13, 2025, four people infected with the outbreak strain of Salmonella Oranienburg have been reported from two states.  The Minnesota Department of Agriculture collected and tested pistachio cream from the restaurant where sick people reported eating. WGS from these samples showed that the Salmonella in the pistachio cream is closely related to bacteria from the sick people, confirming the pistachio cream as the source of the outbreak.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-market-recalls-emek-spread-pistachio-cacao-cream-kadayif-due-salmonella-contamination
World Market Recalls Emek Spread Pistachio Cacao Cream with Kadayif Due to Salmonella Contamination
Summary
Company Announcement Date:  July 14, 2025
FDA Publish Date:  July 14, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  World Market
Brand Name:  Emek
Product Description:  Spread Pistachio Cacao Cream with Kadayif

Company Announcement

FDA Issue Warning Letter to PA Producer of Raw Pet Food

FDA issued a Warning Letter to Answers Pet Food of Elizabethville, PA after an investigation that was triggered by samples of pet food testing positive for Salmonella and Listeria.

"August 22, 2024, an FDA Investigator purchased samples of your Answers raw pet food from a retailer in Nevada in response to consumer complaints. Sample analysis revealed that all four sampled lots contained Salmonella and/or Listeria monocytogenes, as described below. Therefore, your Answers Pet Food Raw Beef Detailed Formula, lot May 06 2026, Answers Pet Food Raw Beef Straight Formula, lot Jan 31 2026, and your Answers Pet Food Straight Chicken Formula, lots Jan 02 2026 and Mar 11 2026, are adulterate"

First, the fact that the pathogens were present, meant that identified preventive controls were not adequate.

"Your food safety plan identifies process, sanitation, and supply chain preventive controls as part of your “(b)(4) technology” to control pathogens. Yet, your preventive controls are not adequate as shown by the following samples of four products collected at retail and analyzed by FDA that contain Salmonella, L. monocytogenes, or both:"

The company identified sanitation preventive controls, but were not sufficient because Salmonella was present in the environment.

"Your hazard analysis identified Sanitation Standard Operating Procedures (SSOPs) and current good manufacturing practices (CGMPs) as a preventive control for biological hazards (which include pathogens) in your raw pet food at steps (b)(4) of your whey mixture containing lactic acid bacteria (LAB). Inspectional findings that indicate your sanitation preventive control is inadequate include:

i. FDA Investigators collected environmental samples on July 23, 2024, under sample 1263703, that revealed the presence of L. monocytogenes on seven surfaces in your facility, including Zone (b)(4) food-contact surfaces."

The company identified supply chain preventive controls, but did not have evidence for that control.

"you were unable to provide COAs for turkey and pork ingredients used to manufacture your raw pet food between July 22 and July 24, 2024"   "You did not provide documentation of annual onsite audits for your suppliers during the inspection, and you do not have a written justification for accepting LOGs and/or COAs from ingredient suppliers in lieu of an annual onsite audit at your suppliers."

GMP issues were also noted in this report.


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lystn-llc-dba-answers-pet-food-694680-06182025
Lystn LLC dba Answers Pet Food

FDA Reports Cucumber-linked Salmonella Outbreak Over, No Information on Source at Farm

FDA has released notice the the Salmonella outbreak associated with cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and distributed by Fresh Start Produce Sales, Inc., of Delray, Florida, is over. There have been 69 total cases with 22 hospitalizations.

Epidemiologic and traceback information demonstrated that cucumbers grown by Bedner Growers, Inc., in Boynton Beach, Florida, were the source of illnesses in this outbreak.  As part of this investigation, FDA collected a product sample of Bedner Growers, Inc., cucumbers from a distribution center in Pennsylvania. Salmonella was detected in the sample of cucumbers. Whole Genome Sequencing analysis determined that the product sample contained Salmonella Montevideo, which matched the strain of Salmonella linked to illnesses in this outbreak.

Case Counts
Total Illnesses: 69
Hospitalizations: 22
Deaths: 0
Last Illness Onset: May 29, 2025
States with Cases: AL, CA, CO, FL, GA, IL, IN, KS, KY, MD, MA, MI, MS, NC, NJ, NY, OH, PA, SC, TN, and VA
Product Distribution: Nationwide

Outbreak Investigations & Safety Advisories
FDA Human Foods Program
Outbreak Investigation of Salmonella: Cucumbers (May 2025)
CDC declares outbreak over. FDA’s investigation is complete.

Current Update
June 30, 2025

FDA Issues Warning Letter to CA Manufacturer of Pizza and Sandwiches

FDA issues a Warning Letter to Revolution Foods of Commerce, CA. a manufacturer of ready-to-eat (RTE) packaged food products including cheese pizzas and cheese sandwiches.  Some of the highlights of this report include:

• Although the company evaluated the hazard of undeclared allergens due to incorrect labels at the packaging and labeling application step, they did not identify it as a hazard requiring a preventive control and did not include any rationale for not doing so. The facility manufactures packaged food products containing different allergenic profiles, such as  Double Cheese Torta sandwich (milk, soy, and wheat) and Cheese Pizza Kits (milk, soy, and wheat) so should have identified allergens as a concern.
• The hazard analysis for “Ready to Eat: Hot & Cold Entrees, Wraps, Salads, Snacks and Beverages” identified contamination with vegetative pathogens (cross-contamination) as a hazard requiring a preventive control at the (b)(4) steps (where RTE food is exposed to the environment prior to packaging). The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. The written sanitation procedures (“SSOPs”) which identify cleaning and sanitizing operations for equipment and the facility. However, these procedures did not address monitoring of employee handwashing prior to donning gloves and touching RTE ingredients that they assemble into packaged meals, such as Double Cheese Torta sandwiches and Cheese Pizza Kits.
• In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). However, there was no environmental monitoring program.
• There were also some misbranding issues.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revolution-foods-pbc-690586-04072025

WARNING LETTER
Revolution Foods, PBC
MARCS-CMS 690586 — April 07, 2025

FDA Issues Warning Letter To California Baker for Lack of Sanitation Controls

FDA issued a Warning Letter to Marin Baking LLC, a manufacturer of ready-to-eat (RTE) bread products, located in San Rafael, CA.  There were a number of issues including:

• Allergen preventive controls did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and for food labeling to ensure the food is not misbranded 
• Sanitation procedures were not completely followed, including not following schedule cleaning procedures.  
• Did not have adequate sanitation verification procedures.
• Did not have adequate controls in place for allergen cross-contact, as evidenced by observations involving sesame seeds. 
• The facility’s written hazard analysis did not consider recontamination with environmental pathogens, such as Salmonella, at all steps where  RTE bread products are exposed to the environment. 
• There were issues with rodents and insects.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/marin-baking-llc-700600-05282025
WARNING LETTER

Marin Baking LLC
MARCS-CMS 700600 — May 28, 2025
Recipient:
Farid M. Radwan, Co-owner
Michael D. Humphrey, Co-owner
Marin Baking LLC
1512 4th Street
San Rafael, CA 94901
United States

Salmonella Outbreak Linked to Eggs Impacts 79, CA Firm Recalls Implicated Eggs

FDA and CDC report that there is an ongoing Salmonella outbreak related to raw eggs distributed by the August Egg Company of Hilmar, CA.  To this point, there have been  a total of 79 people infected with the outbreak strain of Salmonella from seven states.  There have been 21 hospitalizations, and no deaths have been reported. "Illnesses started on dates ranging from February 24, 2025, to May 17, 2025. Twenty-seven of 30 cases with information available reported exposure to eggs or an egg containing dish before becoming ill."

FDA also conducted an inspection and collected environmental samples at August Egg Company’s processing facility. Two samples from this inspection were positive for Salmonella and found to be a Whole Genome Sequencing (WGS) match to the strain of Salmonella causing illnesses in this outbreak.

"Based on WGS analysis, bacteria from 79 people's samples predicted resistance to nalidixic acid and nonsusceptibility to ciprofloxacin (NSC); this NSC strain is related to a strain of Salmonella Enteritidis isolated from chicken, eggs, and backyard poultry. One person's samples also predicted an additional resistance to ampicillin and streptomycin. Most people with Salmonella illness recover without antibiotics. However, if antibiotics are needed, some illnesses in this outbreak may not be treatable with some commonly recommended antibiotics and may require a different antibiotic choice."

August Egg Company of Hilmar, CA is recalling 1,700,000 dozen brown cage free and brown certified organic eggs.  "Recalled brown cage free eggs and brown certified organic eggs were distributed from February 3, 2025, through May 15, 2025, with sell by dates from March 4, 2025, to June 4, 2025, in California and Nevada to retail locations including Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less, and Ralphs.  The eggs were also distributed from February 3, 2025, through May 6, 2025, with sell by dates from March 4, 2025, to June 19, 2025, to Walmart locations in California, Washington, Nevada, Arizona, Wyoming, New Mexico, Nebraska, Indiana, and Illinois."

August Egg Company began diverting all eggs to an egg breaker in May 2025. This breaking facility processes eggs to eliminate the Salmonella risk.

FDA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-eggs-june-2025
Outbreak Investigation of Salmonella: Eggs (June 2025)

Do no eat, sell, or serve recalled chicken eggs distributed by August Egg Company. FDA’s investigation is ongoing.

Case Counts
Total Illnesses: 79
Hospitalizations: 21
Deaths: 0
Last Illness Onset: May 17, 2025
States with Cases: AZ, CA, KY, NE, NJ, NV, WA
Product Distribution*: AZ, CA, IL, IN, NE, NM, NV, WA, WY
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

USDA Issues Health Alert for Ground Meat Products from VT Establishment That May Contain Pathogenic E. coli

The USDA-FSIS is issuing a public health alert for ground beef products produced by NPC Processing Inc. of Shelburne, VT that may be contaminated with E. coli O157:H7. A recall was not requested because the products are no longer available for purchase.  The problem was discovered when the establishment notified FSIS that they shipped into commerce ground beef product that tested positive for E. coli O157:H7.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ground-beef-products-due-possible-e--coli-o157h7-1
FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. Coli O157:H7 Contamination

WASHINGTON, June 3, 2025 - The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert for ground beef products that may be contaminated with E. coli O157:H7. FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed. A recall was not requested because the products are no longer available for purchase.

FDA Updated Information on Salmonella Outbreak Linked to Cucumbers and Recall Information

FDA and CDC updated the information on the multistate outbreak of Salmonella Montevideo infections linked to cucumbers grown by Bedner Growers, Inc., in Boynton Beach, Florida, and distributed by Fresh Start Produce Sales, Inc., of Delray, Florida. As of May 30, there have been 45 illnesses with 16 hospitalizations.

There have been nine associated recalls where the cucumbers were sold whole or fresh processed.

Three additional recalls added last week were:

• Isabelle’s Kitchen Inc. Recalls Refrigerated Deli Salads Containing Fresh Cucumbers Because of Possible Health Risk    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/isabelles-kitchen-inc-recalls-refrigerated-deli-salads-containing-fresh-cucumbers-because-possible
• The Coastal Companies Issues Voluntary Recall on Items with Fresh Start Cucumbers Due to the Potential for Salmonella Contamination   https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/coastal-companies-issues-voluntary-recall-items-fresh-start-cucumbers-due-potential-salmonella
• Supreme Service Solutions LLC Voluntarily Recalls Supreme Vegetable Products Because of Possible Health Risk    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/supreme-service-solutions-llc-voluntarily-recalls-supreme-vegetable-products-because-possible-health-0

Case Counts
Total Illnesses: 45
Hospitalizations: 16
Deaths: 0
Last Illness Onset: May 10, 2025
States with Cases: AL, CA, CO, FL, GA, IL, IN, KS, KY, MA, MI, NC, NY, OH, PA, SC, TN, and VA
Product Distribution: Nationwide

FDA Outbreak Investigation Notice
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-may-2025
Outbreak Investigation of Salmonella: Cucumbers (May 2025)
Current Update
May 30, 2025

Additional Recalls Issued for Products that Used Cucumbers Recalled for Salmonella

Four associated recalls were issued for cucumber and cucumber products as part of the Bedner Growers cucumber recall. 

• PennRose Farms, LLC of Wellington FL is recalling 5-pound mesh bags of whole cucumbers. PennRose Farms repacked some of these cucumbers in 5-pound mesh bags (1,152 cases or 9,216 individual units) showing Restaurant Depot and PennRose Farms logos.
• Ukrop’s Homestyle Foods, LLC, Richmond, VA announced today that it is recalling three of its Marinated Cucumber Salad products.
• Walmart Inc. is voluntarily recalling Marketside Fresh Cut Cucumber Slices, produced in select stores located in Texas
• Big Y Foods of Springfield, MA is voluntarily recalling some Made-To-Order Subs, Wraps and Paninis sold between 5/20 and 5/21 in some Massachusetts and Connecticut retail stores.  Big Y Foods was notified by Smartcuts that the sliced cucumber distributed to Big Y Foods was impacted by the ongoing Bedner Growers Inc. Cucumber Outbreak investigation.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pennrose-farms-issues-recall-whole-cucumbers-because-possible-health-risk
PennRose Farms Issues Recall of Whole Cucumbers Because Of Possible Health Risk
Summary
Company Announcement Date:  May 21, 2025
FDA Publish Date:  May 22, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  PennRose Farms, LLC
Brand Name:  PennRose Farms
Product Description:  Whole cucumbers