Wednesday, October 1, 2025

MN Candy Company Recalls Chocolate Candy Product for Undeclared Cashews

Abdallah Candies is voluntarily recalling a specific lot of Pecan Caramel Clusters, due to a mislabeled allergen. Product contains Cashews that were not listed on the product label.  The recall was initiated after a guest who purchased the Pecan Caramel Clusters discovered the mislabeled cashew allergen.

Product was sold and distributed exclusively to Lunds & Byerlys, as a private label, sold in the state of Minnesota. 


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abdallah-candies-issues-voluntary-recall-pecan-caramel-clusters-due-undeclared-mislabeled-allergens
Abdallah Candies Issues a Voluntary Recall of Pecan Caramel Clusters Due to Undeclared, Mislabeled Allergens
Summary
Company Announcement Date:  September 30, 2025
FDA Publish Date:  September 30, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Due to a mislabeled allergen, cashews
Company Name:  Abdallah Inc.
Brand Name:  Lunds & Byerlys
Product Description:  Chocolate candy with nuts.

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

Small CA Soy Bean Processor Issued Warning Letter with Multiple Violations

FDA issued a Warning Letter to Tan Nam Corporation, a producer of ready-to-eat (RTE) and ready-to-drink (RTD) soybean products facility, located in Rosemead, CA .   This is a very small company, that would be considered  Qualified in terms of compliance (they do not need a formalized Food Safety Plan, but still have to have the necessary controls in place for safety).

It seems that this was more of a restaurant operation that was distributing product.   Because they were distributing, the first thing they need to do, but failed, was registering their facility.  Then they would file an attestation with FDA regarding their 'qualified' status.  That did not occur either.

What follows in the report is a laundry list of GMP violations, any of which could result in signification food safety issues.  Everything from lack of temperature control throughout the process to bad sanitation.

It is easy to overlook these small operations, but the same rules of food safety apply regardless of size.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tan-nam-corporation-708292-08252025
Tan Nam Corporation
MARCS-CMS 708292 — August 25, 2025

Importers Continue to Fail to Meet FSVP Requirements

Here are two recent examples of food importers who were cited for not addressing FSVP requirements for the food products that they import.

Ever Rich Foods LLC, Edison, NJ, did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a) for any of the foods the company imports including:
  • Sweet Kala Jamoon from the foreign supplier (b)(4) located in (b)(4).
  • Kaju Pista Roll – Sweets from the foreign supplier (b)(4) located in (b)(4).
  • Motichoor Ladoo from the foreign supplier (b)(4) located in (b)(4).

Delicias Del Country USA Inc Laredo, TX did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import including the following foods:
  • Sweet Kala Jamoon from the foreign supplier (b)(4) located in (b)(4).
  • Kaju Pista Roll – Sweets from the foreign supplier (b)(4) located in (b)(4).
  • Motichoor Ladoo from the foreign supplier (b)(4) located in (b)(4).

FDA Warning Letters
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/delicias-del-country-usa-inc-709970-07162025
Ever Rich Foods LLC
MARCS-CMS 715321 — September 12, 2025

FDA Warning Letter to Company Selling THC Gummies Highlights Growing Concern

FDA issued a Warning Letter to a Florida company that sells THC Gummies.  FDA focused on those products containing Delta-8 THC, but this and other cannabinoids are not allowed for food use.
"We note that your firm sells food products that contain cannabinoids other than Delta-8 THC. We know of no basis to conclude that any use in food of a cannabinoid, plant derived or otherwise, would be safe and lawful. For some cannabinoids, such as Delta-8 THC, the available data raise serious concerns about potential harm. For other cannabinoids, there is little or no available information concerning the safety of their use in food. No cannabinoid, plant derived or otherwise, is approved for any use in food as a food additive. Moreover, we know of no basis to conclude that any intended use in food of any cannabinoid satisfies the criteria for eligibility for GRAS status.
There was not inspection, as it appears, but this was from information obtained from the company's internet site.
The "U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address stnrcreations.com in March 2025 and determined that you take orders there for various human food products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). FDA has determined that your products, STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Nana Berry Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. § 331(a)."
FDA states that there is an increasing amount of companies selling such products, and it is a concern.
FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products, including for your Delta-8 and Delta-9 Watermelon Lemonade product specifically; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children
So what is Delta-8 THC and how does it differ from what we normally consider THC from marijuana?  This was a nice summary article in Forbes (https://www.forbes.com/health/cbd/delta-8-vs-delta-9/)
"Delta-8 THC is a naturally-occurring cannabinoid (a type of chemical in marijuana) in the cannabis sativa plant. However, as delta-8 typically occurs in relatively low quantities in the plant, the delta-8 found in retail CBD or cannabis products is often synthetically developed through a process of chemically converting CBD into delta-8.

Delta-8 and delta-9 THC produce similar psychoactive effects, but the effects from delta-8 are less potent. This is a result of the way delta-8 binds to the body’s endocannabinoid system (ECS), which regulates many functions in the central nervous system, including emotional and cognitive processing behavior, mood and more. Delta-8 binds to this system via a double bond structure in a particular carbon, which creates the psychoactive intoxicating effect, but to a lesser degree compared to delta-9.

“Delta-8 is a cannabinoid (cannabis-like molecule) that is very similar to the main active ingredient of regular cannabis, delta-9,” says Peter Grinspoon, M.D., a physician at Massachusetts General Hospital, instructor at Harvard Medical School, cannabis specialist and author of Seeing Through the Smoke: Cannabis: An Expert Doctor Untangles the Truth About Cannabis. “It functions by triggering our cannabinoid receptors in the same way that cannabis does.”

However, it’s worth noting that due to delta-8’s low natural presence in the cannabis sativa plant, artificially produced formulations of delta-8 may expose users to higher levels of the cannabinoid than they’d experience when using non-synthetic CBD. Additionally, commercially sold delta-8 and products containing delta-8 aren’t regulated by the U.S. Food and Drug Administration (FDA), meaning the chemical process by which the cannabinoids are made and the sanitary standard of the factories in which they’re made are also unregulated, potentially exposing users to unwanted risk and harm, according to the FDA."
FDA Warning Letters
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stnr-creations-llc-698700-07162025
STNR Creations, LLC
MARCS-CMS 698700 — July 16, 2025

MN Produce Distributor Recalls Fresh Cut Cantaloupe After Testing Finds Listeria

Wholesale Produce Supply of Minneapolis, Minnesota is recalling fresh cut/processed cantaloupe, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of a routine sampling program by the company which revealed that the finished products potentially contained bacteria. Wholesale Produce Supply has suspended production and distribution of the affected lots as the company continues their investigation as to what caused the problem.  
No illnesses have been reported to date.

This indicates that the environmental sampling program found Listeria and the company has decided to recall product as part of their corrective action.

Fresh Cut Cantaloupe was sold to distributors in Nebraska, North Dakota and Wisconsin, who may have distributed into other states under the “Harvest Cuts” and “Fresh and Finest” brand at traditional grocery locations.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wholesale-produce-supply-minneapolis-minnesota-recalling-fresh-cutprocessed-cantaloupe-because-it
Wholesale Produce Supply of Minneapolis, Minnesota is Recalling Fresh Cut/Processed Cantaloupe, Because it has the Potential to be Contaminated With Listeria Monocytogenes
Summary
Company Announcement Date:  September 29, 2025
FDA Publish Date:  September 29, 2025
Product Type:  Food & Beverages  Fruit/Fruit Product
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Wholesale Produce Supply, LLC.
Brand Name:  Wholesale Produce Supply, LLC.
Product Description:  Fresh Cut Cantaloupe

Tuesday, September 30, 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.

Monday, September 29, 2025

Freeze Dried Products Recalled for Metal Foreign Material After Complaint

Tru Fru, LLC, Salt Lake City, UT, announced that its third-party manufacturer, Georgia Nut Company (GNC) issued a voluntary recall of specific varieties of Tru Fru Freeze Dried products due to the potential presence of metal in the product. The recall was initiated upon receiving a report from a consumer alerting the company to this matter.

There have been no reported cases of injury or illness to date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/georgia-nut-company-gnc-third-party-manufacturer-tru-fru-llc-issues-voluntary-recall-specific
Georgia Nut Company (GNC), Third-Party Manufacturer for Tru Fru, LLC Issues Voluntary Recall of Specific Varieties of Tru Fru Freeze Dried Products Due to Potential Presence of Metal in Product
Summary
Company Announcement Date:  September 26, 2025
FDA Publish Date:  September 29, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Due to potential presence of metal in the product.
Company Name:  Georgia Nut Company
Brand Name:  Tru Fru
Product Description:  Freeze Dried Fruit snacks

Corn Dogs and Sausage on Stick Products Recalled for Foreign Material - Wood

The Hillshire Brands Company, a Haltom City, Tex. establishment, is recalling approximately 58,000,000 pounds of corn dog and sausage on a stick products that may be contaminated with extraneous material, specifically pieces of wood embedded in the batter.  The problem was discovered after the establishment received multiple consumer complaints, five of which involved injuries. The Hillshire Brands Company conducted an investigation and determined that the wooden sticks entered the production process prior to product battering. 

In this case, wood used for the sticks has made its way into the process to end up as a foreign material.  So perhaps rework?


https://www.fsis.usda.gov/recalls-alerts/hillshire-brands-company-recalls-corn-dog-and-sausage-a-stick-products-due-possible
The Hillshire Brands Company Recalls Corn Dog and Sausage On A Stick Products Due To Possible Extraneous Matter Contamination

FSIS Announcement

WASHINGTON, September 27, 2025 – The Hillshire Brands Company, a Haltom City, Tex. establishment, is recalling approximately 58,000,000 pounds of corn dog and sausage on a stick products that may be contaminated with extraneous material, specifically pieces of wood embedded in the batter, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.