FDA Warning Letter to Processor of RTE Smoothie Mix Highlights Common Food Safety Plan Issues

FDA issued a Warning Letter to a Charlotte NC company that manufactures blender bombs....a mixture of ingredients that are put into the blender with juices or other liquid.  This is a RTE product because there will be no lethal step provided by the consumer.

This Warning Letter highlights additional issues that are important when writing and implementing the plan.  

The company did not consider pathogens as a hazard in this RTE product.

"The hazard analysis contained in your Food Safety Plan for Cold Pressed (Unbaked Products), dated October 17, 2022 (“food safety plan”), did not consider vegetative bacterial pathogens as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds to determine whether they require a preventive control. You contract manufacture RTE “Java Jolt Blender Bombs” containing these ingredients, which have been associated with vegetative bacterial pathogens (such as Salmonella spp.). These ingredients do not receive a lethal treatment in your facility."

The hazard analysis contained in your Food Safety Plan for Cold Pressed (Unbaked Products), dated October 17, 2022 (“food safety plan”), did not consider vegetative bacterial pathogens as a known or reasonably foreseeable hazard for coffee, hemp seeds, and chia seeds to determine whether they require a preventive control. You contract manufacture RTE “Java Jolt Blender Bombs” containing these ingredients, which have been associated with vegetative bacterial pathogens (such as Salmonella spp.). These ingredients do not receive a lethal treatment in your facility.

The metal detector was identified as a preventive control, but was not operated as though it was a preventive control.  What is more interesting is that the response to FDA  was not adequate.  It is important when responding that one not only shows it was fixed, but provide proof the fix actually works.

"We reviewed your response, including the video you sent showing products being sent through a machine, which was presumably a metal detector. Although your response indicates that this machine was a metal detector, and you provide a metal detector drawing (dated November 19, 2015) that presumably depicts the equipment shown in the video, the video does not provide a complete view of the equipment to allow us to confirm what is being shown. Further, you did not provide any metal detection monitoring records to document the results of the metal detection activity purportedly being shown in the video."

Another issue was environmental pathogens as a hazard but did not put in proper sanitation preventive controls. 

[The company] "did not implement your sanitation preventive control for the environmental pathogens hazard. Your food safety plan identifies environmental pathogens as a hazard requiring a preventive control at various processing steps, such as mixing, tumbling, coating, and packaging, where the RTE “Java Jolt Blender Bombs” are exposed to the environment. These steps occur prior to your products being sealed. 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 company did not follow their own procedures on following corrective actions for a positive Listeria species finding.

You did not follow the corrective actions outlined in your Environmental Monitoring – Listeria procedures, dated June 1, 2021, when you were notified of a presumptive positive Listeria spp. finding on August 24, 2023, for which your facility waived confirmation. According to your Environmental Monitoring – Listeria procedures in effect at the time, when a positive Listeria spp. result occurred, your facility would conduct follow-up environmental sampling that consisted of “(b)(4) swabs total; (b)(4) swabs a day taken on (b)(4) consecutive production days” and send the swabs to a third-party laboratory for analysis. However, your Microbiological Swab Test Logs from August 24-26, 2023, showed that a total of only (b)(4) swabs were taken ((b)(4) swab per day) instead of the required (b)(4) swabs total. Furthermore, instead of sending the swabs to your third-party laboratory for analysis, you tested the swabs in-house.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/golden-grains-bakery-688860-12202024
Golden Grains Bakery

MARCS-CMS 688860 — December 20, 2024
Recipient:
Marc L. Singer, Owner
Ronald L. Nadel, Owner
Golden Grains Bakery
547 Griffith Road
Charlotte, NC 28217-3517
United States

USDA Issues Alert for Frozen Ham Croquets with Undeclared Soy and Sesame Due to Ingredient Change

USDA -FSIS is issuing a public health alert for a frozen not-ready-to-eat ham croquette product due to misbranding and undeclared allergens. The product contains soy and sesame, known allergens, which are not declared on the product label.  The problem was discovered during routine FSIS in-plant labeling verification activities. The establishment used a different breadcrumb ingredient than normally used.

From what is indicated here, the company made an ingredient change with a breading material and did not properly vet the new item for allergens.


https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-not-ready-eat-ham-croquette-product-due-misbranding
FSIS Issues Public Health Alert for Not-Ready-To-Eat Ham Croquette Product Due to Misbranding and Undeclared Allergens

WASHINGTON, June 2, 2025 – The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert for a frozen not-ready-to-eat ham croquette product due to misbranding and undeclared allergens. The product contains soy and sesame, known allergens, which are not declared on the product label. FSIS is issuing this public health alert to ensure that consumers with allergies to soy and sesame are aware that this product should not be consumed. A recall was not requested because the affected product is no longer available for purchase.

The frozen not-ready-to-eat ham croquette item was produced on various dates in April and May 2025. The following product is subject to the public health alert [view labels]:

1.96-lb. boxes containing "HAM CROQUETTES Las que si tienen el sabor cubano A TASTE OF CUBA CROQUETAS DE JAMÓN" with expiration dates of "November 2025," "December 2025" and "January 2026" printed on the boxes.

The product bears establishment number "EST. 2725" inside the USDA mark of inspection. This item was shipped to distributor locations in Florida.

The problem was discovered during routine FSIS in-plant labeling verification activities. The establishment used a different breadcrumb ingredient than normally used.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an adverse reaction should contact a healthcare provider.

FSIS is concerned that some product may be in consumers' freezers. Consumers who have purchased this product are urged not to consume it. The product should be thrown away or returned to the place of purchase.

Media and consumers with questions regarding the public health alert can contact Hernesto Aguirre, Owner, at croquetaslamary@gmail.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Large Recall of Canned Stew After Complaints for Pieces of Wood

Hormel Foods Corporation, a Tucker, Ga. establishment, is recalling approximately 256,185 pounds of canned beef stew (Dinty Moore BEEF STEW” with “BEST BY FEB 2028)  product that may be contaminated with foreign material, specifically wood.  The problem was discovered after the establishment notified FSIS that they had received three consumer complaints reporting pieces of wood in the beef stew product.  There have been no confirmed reports of injury due to consumption of this product. 

From this, it appears the entire day's production if being recalled...probably over 100 pallets of product...for wood contamination.  There are not many recalls due to wood, but this is way we avoid the use of wood in processing settings outside of pallets.  So could this be the result of a piece of wood broken off from a pallet?

https://www.fsis.usda.gov/recalls-alerts/hormel-foods-corporation-recalls-canned-beef-stew-product-due-possible-foreign
Hormel Foods Corporation Recalls Canned Beef Stew Product Due to Possible Foreign Matter Contamination

FSIS Announcement

WASHINGTON, May 28, 2025 – Hormel Foods Corporation, a Tucker, Ga. establishment, is recalling approximately 256,185 pounds of canned beef stew product that may be contaminated with foreign material, specifically wood, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Georgia Firm Recalls Bread & Batter Mix For Undeclared Milk After Reported Illness

Homegrown Family Foods of Rome, GA is recalling its Shore Lunch Oven Style Breader & Batter Mix 6oz Box due to the presence of undeclared milk.  On 4/23/2025, the firm was notified by a consumer whose daughter had an allergic reaction. The recall was initiated after it was discovered that product containing the milk ingredient was in packaging that did not properly label the presence of milk

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homegrown-family-foods-issues-allergy-alert-undeclared-milk-shore-lunch-oven-style-breader-batter
Homegrown Family Foods Issues Allergy Alert on Undeclared Milk in Shore Lunch Oven Style Breader & Batter Mix
Summary
Company Announcement Date:  May 29, 2025
FDA Publish Date:  May 29, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Presence of Undeclared Milk
Company Name:  Homegrown Family Foods
Brand Name:  Shore Lunch
Product Description:  Breading and Batter Mix

California Seafood Company Recalls Stuffed Salmon Due to Undeclared Soy

Santa Monica Seafood of Rancho Dominguez, CA, is voluntarily recalling Atlantic Salmon Portions with Seafood Stuffing because it may contain undeclared soy.   The supplier identified the problem during a routine inspection of label proofs from a completed production batch. This recall was initiated because the product contains soy, a known allergen, but the packaging does not list it as an ingredient.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/santa-monica-seafood-voluntarily-recalls-atlantic-salmon-portions-seafood-stuffing-due-undeclared
Santa Monica Seafood Voluntarily Recalls Atlantic Salmon Portions with Seafood Stuffing Due to Undeclared Soy
Summary
Company Announcement Date:  May 24, 2025
FDA Publish Date: May 24, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - soy
Company Name:  Santa Monica Seafood
Brand Name:  Aldi
Product Description:  Atlantic Salmon Portions with Seafood Stuffing

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

Utah Bakery Reissues Recall of Bakery Items for Undeclared Allergens to Include Tree Nuts

New Grains Gluten Free Bakery of Spanish Fork, Utah is reissuing a May 9 recall where the company recalled a variety of products, including breads, bagels, cookies, and croutons, because they may contain undeclared eggs, tree nuts, soy, and milk.  

The reissue was to add tree nuts to the allergens that were undeclared.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/new-grains-gluten-free-bakery-issues-allergy-alert-undeclared-eggs-tree-nuts-soy-and-milk-bakery
New Grains Gluten Free Bakery Issues Allergy Alert on Undeclared Eggs, Tree Nuts, Soy, and Milk in Bakery Products
Summary
Company Announcement Date:  May 21, 2025
FDA Publish Date:  May 22, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Allergen – Egg, tree nuts Soy and Milk
Company Name:  New Grains Gluten Free Bakery
Brand Name:  New Grain Gluten Free Bakery
Product Description:  Breads, bagels, caramel bars, cookies and croutons

Publix Recalls Baby Food After FDA Sampling Detects Lead

Publix Super Markets, Inc. has initiated a voluntary recall of GreenWise Pear, Kiwi, Spinach & Pea Baby Food, produced by Bowman Andros LLC and distributed to Publix grocery stores in the company’s eight-state operating area. The product is sold in 4-ounce plastic pouches and has the potential to be contaminated with elevated levels of lead.  This recall is being initiated as a result of routine sampling and is being made with the knowledge of the U.S. Food and Drug Administration.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/publix-voluntarily-recalls-greenwise-pear-kiwi-spinach-pea-baby-food-pouches-due-lead
Publix Voluntarily Recalls GreenWise Pear, Kiwi, Spinach & Pea Baby Food Pouches Due to Lead
Summary
Company Announcement Date:  May 09, 2025
FDA Publish Date:  May 22, 2025
Product Type:  Dietary Supplements
Reason for Announcement:  Product may be contaminated with elevated levels of lead
Company Name:  Publix
Brand Name:  GreenWise
Product Description:  Pear, Kiwi, Spinach & Pea Baby Food pouches

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