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

Michigan Confectionary Company Recalls Boxes of Chocolates for Undeclared Pecans

Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans.   The recall was initiated after it was discovered that a product containing pecans was distributed in packaging that did not reveal the presence of pecans.

The recalled Mocha Truffles were distributed by Kilwins Quality Confections, LLC., and may have been sold at nine (9) Kilwins retail stores in the following cities: Orange Beach, AL, located at 4751 Main St, Unit F113; Coral Springs, FL; Vero Beach, FL; Winter Park, FL; Thomasville, GA; Annapolis, MD; Portsmouth, NH; Wilmington, NC, located at 16 Market St; and Alexandria, VA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilwins-quality-confections-llc-issues-allergy-alert-undeclared-pecans-mocha-truffles
Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles
Summary
Company Announcement Date:  June 25, 2025
FDA Publish Date:  June 25, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared pecans
Company Name:  Kilwins Quality Confections, LLC
Brand Name:   Kilwins
Product Description:  Mocha Truffles

USDA Issues Health Alert for Meat Sauce Produced Without Inspection by Indiana Establishment

USDA - FSIS is issuing a public health alert for meat sauce products produced without the benefit of federal inspection. The producer, Thompson’s Spanish Sauce Manufacturing, LLC, in Marion, Ind., does not have a federal grant of inspection. FSIS is issuing a public health alert because the company was unavailable to confirm their actions to remove affected products from commerce  The problem was discovered during routine FSIS surveillance activities at a retail location in Roann, Ind., where FSIS investigators identified these thermally-processed meat sauce products for sale without a federal mark of inspection.

You wonder how they got this far without knowing more regarding regulations.

FSIS Issues Public Health Alert for Meat Sauce Products Produced Without the Benefit of Inspection | Food Safety and Inspection Service
FSIS Issues Public Health Alert for Meat Sauce Products Produced Without the Benefit of Inspection

Oregon Firm Recalls Cheese Curds After Company Testing Finds Listeria

Face Rock Creamery of Bandon, Oregon is voluntarily recalling two specific lots of its Vampire Slayer Garlic Cheddar Curds, 6oz. cups, Use By date 08292025, 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 contained the bacteria. The company has notified U.S. FDA and Oregon Department of Agriculture, and the company continue their investigation as to what caused the problem.

The affected product was distributed in Trader Joe’s locations in Northern California (locations in Monterey, Fresno and all locations North) and Northern Nevada (locations in Carson City, Reno, and Sparks), and is identified by the following information:


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/face-rock-creamery-voluntarily-recalls-vampire-slayer-garlic-cheddar-curds-because-possible-health
Face Rock Creamery Voluntarily Recalls Vampire Slayer Garlic Cheddar Curds Because of Possible Health Risk
Summary
Company Announcement Date:  June 20, 2025
FDA Publish Date:  June 21, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness – Listeria monocytogenes
Company Name:  Face Rock Creamer
Brand Name:  Face Rock Creamery
Product Description:  Vampire Slayer Garlic Cheddar Curds

Florida Firm Recalls Chocolate Mousse for Not Listing Allergens on Package

Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts (Almonds, Hazelnuts).  The recall was initiated after a routine inspection where it was discovered that product containing allergens was distributed in packaging that did not reveal the presence of Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, and Tree Nuts (Almonds, Hazelnuts). The recalling firm is in the process of implementing corrective actions, including implementing systems to improve labeling, traceability and strengthen our food safety moving forward.

MOUSSE DESSERTS were distributed in Florida, in the areas of Kissimmee and Orlando and they were able to be purchased by consumers in retail stores


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sabores-bakery-dba-sabores-tu-mesa-issues-allergy-alert-undeclared-milk-mousse-desserts
Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
Summary
Company Announcement Date:  June 20, 2025
FDA Publish Date:  June 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Sabores Fit Bakery
Brand Name:  Sabores A Tu Mesa
Product Description:  Mousse Desserts

PA Firm Recalls Dark Chocolate Product for Undeclared Milk Allergens, Two Distributors Also Issue Recalls

Weaver Nut Company, Inc., Ephrata, PA, is recalling the following chocolate products with specific lot codes, due to potential undeclared milk allergens.  The issue was discovered through a wholesale customer complaint upon receipt of shipment misaligned with updated product spec. followed by a lab test to confirm the milk presence.

Two distributor of this product produced by Weaver Nut also issued recalls

• International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils
• Lipari Foods of Warren, MI, is recalling its 14-ounce packages of JLM Branded “Dark Chocolate Nonpareils" 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/weaver-nut-company-inc-issues-allergy-alert-undeclared-milk-chocolate-nonpareils
Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate Nonpareils
Summary
Company Announcement Date:  June 17, 2025
FDA Publish Date:  June 18, 2025
Product Type: Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Weaver Nut Company
Brand Name:  Weaver Nut Company
Product Description:  Semi sweet chocolate pareils with white or Christmas colored seeds

Chicken Alfredo Product Recalled After Linked to Listeria Outbreak Impacting 17 People

FSIS, FDA and public health partners are investigating an outbreak of Lm that are being linked to a chicken fettuccine alfredo product from  FreshRealm.   There are currently includes 17 ill people in 13 states. As of June 17, 2025, there have been three reported deaths and one fetal loss associated with this outbreak.  FreshRealm establishments in San Clemente, Calif., Montezuma, Ga., and Indianapolis, Ind., are recalling chicken fettuccine alfredo products that may be adulterated with the outbreak strain of Listeria monocytogenes (Lm).

The outbreak strain of Lm was isolated from ill people on dates ranging from August 2024 – May 2025. The same outbreak strain was isolated from a routine chicken fettuccine alfredo sample collected by FSIS in a FreshRealm establishment in March 2025. The lot of chicken fettuccine alfredo represented by this sample was held during sampling, destroyed, and never entered commerce. The subsequent investigations at the establishment that produced this product, and into the product ingredients, have not identified the source of contamination. FSIS also used purchase records from two ill people to trace purchased chicken fettuccine alfredo products to FreshRealm establishments. An additional two ill people verbally described chicken fettuccine alfredo products they purchased. FSIS identified products produced by FreshRealm that matched the descriptions during follow-up at the retail stores where they shopped. 

Case Counts

Total Illnesses: 17

Hospitalizations: 16

Deaths: 3

Last Illness Onset: May 10, 2025

States with Cases: FL, IL, IN, LA, MI, MN, MO, NC, NV, OH, SC, TX, VA

Product Distribution: Nationwide

https://www.fsis.usda.gov/recalls-alerts/freshrealm-recalls-chicken-fettuccine-alfredo-products-due-possible-listeria
FreshRealm Recalls Chicken Fettuccine Alfredo Products Due to Possible Listeria Contamination

FSIS Announcement

WASHINGTON, June 17, 2025 – FreshRealm establishments in San Clemente, Calif., Montezuma, Ga., and Indianapolis, Ind., are recalling chicken fettuccine alfredo products that may be adulterated with an outbreak strain of Listeria monocytogenes (Lm), the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Out of an abundance of caution, the company is voluntarily recalling all products produced prior to June 17, 2025, that are available in commerce under the following brand names.

Firm in Puerto Rico Recalls Tallow Produced Without Inspection

King Tallow LLC, in Guaynabo, Puerto Rico, is recalling approximately 353 pounds of beef tallow that was processed, packaged, and labeled without the benefit of federal inspection.  FSIS discovered the problem after FSIS received an anonymous consumer complaint about beef tallow products void of the federal mark of inspection being sold in a retail location in Carolina, Puerto Rico. FSIS determined that King Tallow LLC purchased beef fat from an FSIS-regulated facility and further processed into tallow, portioned into jars, and relabeled the product without the benefit of FSIS inspection. The beef tallow products contain a nutrition facts label, leading people to believe that the product is safe for human consumption. King Tallow LLC does not possess a federal grant of inspection and is not authorized to produce products intended for human consumption.

This item was shipped to retail locations in Puerto Rico and do not bear the USDA mark of inspection.

https://www.fsis.usda.gov/recalls-alerts/king-tallow-llc-recalls-beef-tallow-products-produced-without-benefit-inspection
King Tallow LLC Recalls Beef Tallow Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, June 13, 2025 – King Tallow LLC, in Guaynabo, Puerto Rico, is recalling approximately 353 pounds of beef tallow that was processed, packaged, and labeled without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.