Michigan Firm Recalls No Bake Cookies After Computer Error Causes Formulation Mistake and Adds Undeclared Peanuts

Wesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut.  The recall was initiated after it was discovered that Wesco Mint No Bake Cookie Bites containing peanut butter were distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by incorrect product formulation within the manufacturing facility’s new software system.

Validating software - when new software is installed, it must be thoroughly validated.  Validation should continue through the start of use in production.

Verifying formulations - the strength of a HACCP based system is having double checks in place to ensure product safety.  In this case, a manual check is there to ensure the proper formulation is in place, specifically addressing allergens.  The allergens within the formulation must match what is on the package.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wesco-inc-issues-voluntary-recall-and-allergy-alert-undeclared-peanut-wesco-mint-no-bake-cookie
Wesco, Inc. Issues Voluntary Recall and Allergy Alert on Undeclared Peanut in Wesco Mint No Bake Cookie Bites
Summary
Company Announcement Date:  March 08, 2024
FDA Publish Date:  March 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanut Allergen
Company Name:  Wesco, Inc.
Brand Name:  Wesco Fresh
Product Description:  Mint No Bake Cookies
Company Announcement
Wesco, Inc. of Muskegon, MI is recalling 750 units of Wesco Mint No Bake Cookie Bites, because it may contain undeclared peanut. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA Issues Warning Letter to Firm In Response to the Firm's Nonresponse

FDA issued a Warning Letter to a Michigan firm after the firm failed to respond to FDA's request to provide corrective actions related to a recall the firm had conducted.  The message here, respond to FDA requests.

A summary of the events:

• On September 12, 2023, the firm recalled Knickerbocker Homestyle Hamburger Buns after the firm discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. 
• The firm became aware of this undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at the facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming the product. 
• In documentation provided to FDA on September 15, 2023, the firm stated that they had reformulated the bun product to include milk powder without changing the packaging to reflect the change. This product had been manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at the facility with packaging that did not declare milk on the label.
• On September 15, 2023, the firm provided documentation that stated that they had determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” The proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.
•  On September 18, 2023, FDA sent  the firm an email giving the firm an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, the firm did not respond. 
• Conclusion - Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-673138-01292024

WARNING LETTER
Knickerbocker 365, Inc.

MARCS-CMS 673138 — JANUARY 29, 2024

NC Company Issues Expanded Recall for Single Slice Carrot Cake and Chocolate Cake Due to Undeclared Soy Allergen

KALO Foods, LLC of Stokesdale NC issue an expanded notice for the recall of  Single Slice Carrot Cake UPC 8 53407 00418 4 and Single Slice Chocolate Cake UPC 8 53407 00418 4 due to undeclared soy.   The initial recall on March 5, 2024 was just for the carrot cake.

Although the package is labeled Carrot Cake, but the ingredient panel and UPC Code is for their Chocolate Cake. The Chocolate Cake labeled products contain slices of Carrot Cake. The Carrot Cake contains soy which is not listed in the ingredient statement

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/expanded-press-release-kalo-foods-llc-recalls-single-slice-carrot-cake-and-chocolate-cake-due
Expanded Press Release – Kalo Foods, LLC Recalls Single Slice Carrot Cake and Chocolate Cake Due to Undeclared Soy Allergen
Summary
Company Announcement Date:  March 06, 2024
FDA Publish Date:  March 08, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Soy
Company Name:  KALO Foods, LLC
Brand Name:  KALO
Product Description:  Single Slices of Carrot Cake & Chocolate Cake

Washington State Establishment Recalls RTE Breakfast Burritos After Sampling Finds Listeria

Jen's Breakfast Burritos, LLC, an Auburn, Wash. establishment, is recalling approximately 144 pounds of ready-to-eat (RTE) breakfast burrito products that may be adulterated with Listeria monocytogenes.  The problem was discovered after FSIS performed routine product testing and the results indicated the product may be contaminated with Listeria monocytogenes. 

https://www.fsis.usda.gov/recalls-alerts/jens-breakfast-burritos-llc-recalls-ready-eat-breakfast-burrito-products-due
Jen's Breakfast Burritos, LLC, Recalls Ready to Eat Breakfast Burrito Products Due to Possible Listeria Contamination

FSIS Announcement

WASHINGTON, March 10, 2024 - Jen's Breakfast Burritos, LLC, an Auburn, Wash. establishment, is recalling approximately 144 pounds of ready-to-eat (RTE) breakfast burrito products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

Minnesota Raw Pet Food Company Cited for Inadequate PAA Process Resulting in Pathogens in Finished Product

FDA issued a Warning Letter to Woody’s Pet Food Deli of  West Saint Paul, MN., a processor of raw pet food products.   During the inspection, FDA took samples and found that Woody’s Pet Food Deli Raw Free Range Turkey with Supplements pet food for dogs and cats, lot code 08/31/24, was contaminated with Salmonella Reading and Listeria monocytogenes.

The firm uses an acetic acid, PAA, and hydrogen peroxide (b)(4), as the method to eliminate pathogens from the raw pet food products. During the inspection, FDA collected an in-process sample (FDA sample #1214888) of Woody’s Pet Food Deli Raw Free Range Turkey with Supplements, lot code 08/31/24,  at a location immediately after the application of the spray and immediately prior to finished product packaging.  This product tested positive for Salmonella Reading and Listeria monocytogenes. Thus the process is not adequate.  Further, the company could not provide any information indicating the use of PAA in pet food is considered GRAS by qualified scientific experts.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agila-corporation-dba-woodys-pet-food-deli-670835-01262024
Agila Corporation dba Woody’s Pet Food Deli
MARCS-CMS 670835 — JANUARY 26, 2024

Illinois Facility Received Warning Letter for Continued Allergen Related Recalls

FDA issued a Warning Letter to Gilster-Mary Lee Corporation of Chester, IL after they determined that the company's recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal (5.2 oz. retail unit, BEST BY FEB 08 24 Y18, UPC 75450-08552), was misbranded within the meaning of the regulation in that the finished product label did not declare a major food allergen, milk. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited.  The  firm had initiated three other recalls involving mislabeled products resulting in undeclared major food allergens since 2019.  Thus the reason they received a Warning Letter.

WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023

Gilster-Mary Lee Corporation
MARCS-CMS 658271 — AUGUST 28, 2023

FDA Issues Warning Letter to CA Juice Company Processing Carrot Juice with Pasteurization

FDA issued a Warning Letter to Barsotti Juice Company, Inc. of Camino, CA after the investigation found that they were processing a low acid carrot juice product with a pasteurization process that creates a Clostridium botulinum issue if the product were to be temperature abused.  

Findings:

• "HACCP / HARPC Plan Q2-2023 dated 25 April 2023 lists the following Critical Limits identified at the Pasteurization Critical Control Point (CCP) (b)(4) limit). You have defined Organic Carrot Juice as a Category III product with a (b)(4). The (b)(4) is not sufficient to inactivate the spores of Clostridium botulinum in carrot juice."
• "Specifically, your HACCP / HARPC Plan Q2-2023 dated 25 April 2023 for fresh, refrigerated Organic Carrot Juice does not identify CCPs at labeling for maintaining product refrigeration, and of finished product refrigerated storage, to control the hazard of Clostridium botulinum growth and toxin formation in Organic Carrot Juice."

The pasteurization process would eliminate vegetative cells, but not spores including spores of Clostridium botulinum.  Those spores would survive the pasteurization, and if held at temperatures above refrigeration temperature for sufficient time, the spores would germinate, and then the cells would grow producing toxin.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/barsotti-juice-company-inc-676447-01302024
Barsotti Juice Company, Inc.

MARCS-CMS 676447 — JANUARY 30, 2024

Recipient:
Barsotti Juice Company, Inc.
2239 Hidden Valley Lane
Camino, CA 95709
United States

Maine Facility Recalls Gluten Free Doughnut Mix for Containing Wheat

Stonewall Kitchen of York, Maine is voluntarily recalling a limited amount of their Gluten Free Cinnamon Sugar Doughnut Mix because it may contain an undeclared allergen, wheat.  The recall was initiated after the company received a consumer report of a reaction. Subsequent investigation discovered that product containing wheat was distributed in packaging that did not reveal the presence of wheat due to a packaging process error.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stonewall-kitchen-issues-allergy-alert-wheat-limited-quantity-gluten-free-cinnamon-sugar-doughnut
Stonewall Kitchen Issues Allergy Alert for Wheat in Limited Quantity of Gluten Free Cinnamon Sugar Doughnut Mix
Summary
Company Announcement Date:  March 07, 2024
FDA Publish Date:  March 07, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential or Undeclared Allergen - Wheat
Company Name:  Stonewall Kitchen
Brand Name:  Stonewall Kitchen
Product Description:  Gluten Free Cinnamon Sugar Doughnut Mix

Wisconsin Establishment Recalls Turkey Kielbasa After Complaints for Pieces of Rubber

Salm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber.  The problem was discovered after the firm received complaints from consumers reporting they found pieces of rubber in the ready-to-eat turkey kielbasa products.


https://www.fsis.usda.gov/recalls-alerts/salm-partners-llc-recalls-johnsonville-polish-kielbasa-turkey-sausage-products-due
Salm Partners, LLC, Recalls Johnsonville Polish Kielbasa Turkey Sausage Products Due to Possible Foreign Matter Contamination
SALM PARTNERS, LLC
FSIS Announcement

WASHINGTON, March 7, 2024 - Salm Partners, LLC, a Denmark, Wis., establishment, is recalling approximately 35,430 pounds of Johnsonville turkey kielbasa sausage that may be contaminated with foreign materials, specifically pieces of rubber, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.