CA Processor Recalls Tamales for inadequate Heat Processing Step

Primavera Nueva Inc.,  Sonoma, CA, is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes.  The products were made with a frozen ingredient labeled “Not Ready to Eat. Must Be Thoroughly Cooked Before Eating.” During an FDA inspection on October 10, 2025, the agency determined that earlier production records did not consistently verify internal cooking temperatures needed to control potential biological hazards, including Listeria monocytogenes.  Primavera Nueva has fully corrected the issue—enhanced cooking-temperature monitoring and verification have been in place since October 11, 2025.

This product has heating instructions, but not validated cooking instructions, so the processor is responsible for ensuring the safety of the product to control biological hazards.  If an ingredient is used where there is the potential to have a biological hazard, then a process control in the form of cooking is needed.  From this notice, it appears that the processor did not have a sufficiently validated heating step in place.

Product was distributed by Primavera Nueva Inc. in California and Nevada to retail stores

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/primavera-nueva-inc-issues-voluntary-recall-select-4-count-tamales-because-possible-health-risk

Primavera Nueva Inc. Issues Voluntary Recall of Select 4-Count Tamales Because of Possible Health Risk
Summary
Company Announcement Date:  December 17, 2025
FDA Publish Date:  December 17, 2025
Product Type:  Food & Beverages  Foodborne Illness  
Reason for Announcement:  Potential presence of Listeria monocytogenes.
Company Name:  Primavera Nueva Inc.
Brand Name:  No Brand
Product Description:  Tamales

Retailer Recalls Mislabeled Coffee Cake Due to Undeclared Walnuts

The James Skinner LLC is conducting a voluntary recall of a single lot of Publix Maple Walnut Coffee Cake as the wrong ingredient label was applied to the packaging on certain units. Product was packaged in cases with Maple Walnut Coffee Cake labels but then inadvertently individually labeled as Publix Raspberry Coffee Cake.  This resulted in undeclared walnuts.

Observable through the clear lid, the product has visible walnuts on top of the cake and brown maple topping, whereas Raspberry Coffee Cake has no walnuts on top and red topping. The issue was discovered by a retail store employee who observed the visible walnuts on top of the product and noticed that the product had a Raspberry Coffee Cake label instead of a Maple Walnut Coffee Cake label.

Unfortunately, a quality check did not catch the issue when it was produced.  Clearly, an Allergen Preventive Control for ensuring the proper label is applied is needed in this baking operation, where one could guess that there are a number of different products labeled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/james-skinner-llc-issues-voluntary-recall-publix-maple-walnut-coffee-cake-due-incorrect-labeling

The James Skinner LLC Issues Voluntary Recall of Publix Maple Walnut Coffee Cake Due to Incorrect Labeling
Summary
Company Announcement Date:  December 10, 2025
FDA Publish Date:  December 16, 2025
Product Type:  Food & Beverages  Allergens
Reason for Announcement:  Label does not declare walnuts in the ingredient list.
Company Name:  The James Skinner LLC
Brand Name:  Publix
Product Description:  Publix Raspberry Coffee Cake

Frozen Dessert Products Recalled for Foreign Materials in the Cluster Component

Danone U.S. is voluntarily recalling its So Delicious Dairy Free® Salted Caramel Cluster Non-Dairy Frozen Dessert pints with multiple best-by expiration dates before 08 Aug 2027 at retail stores nationwide due to the potential presence of foreign materials, such as small stones and other hard objects, within the cashew inclusions.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-salted-caramel-cluster-frozen-dessert-pints-voluntarily-recalled-danone-us
So Delicious Dairy Free® Salted Caramel Cluster Frozen Dessert Pints Voluntarily Recalled by Danone U.S. Due to Potential Presence of Foreign Material
Summary
Company Announcement Date:  December 15, 2025
FDA Publish Date:  December 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of foreign materials such as stones and other hard objects.
Company Name:  Danone U.S.
Brand Name:  So Delicious
Product Description:  Non-dairy frozen dessert

Virginia Firm Recalls Cakes Where Undeclared Soy Is Used to Solve Sticking Issue

Ukrop’s Homestyle Foods, LLC, Richmond, VA announced today that it is recalling four of its Decorated Pound Cakes due to an undeclared soy allergen.  A cake releasing agent containing soy was used to prevent sticking for the cakes listed below only.

So this is probably a case where the anti-sticking / pan release agent contained soy lecithin.  The scenario probably goes like this....the facility has a sticking issue on one day of production, and someone sprays on the pan release agent to solve the issue unaware it just created a recallable situation with an undeclared allergen.

This is where employee training on allergens is so important. Also, restrictions on changing process without a thorough review.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ukrops-homestyle-foods-announces-recall-due-undeclared-allergen
Ukrop’s Homestyle Foods Announces Recall Due to Undeclared Allergen
Summary
Company Announcement Date:  December 11, 2025
FDA Publish Date:  December 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared soy
Company Name:  Ukrop;s Homestyle Foods, LLC
Brand Name: Ukrop’s
Product Description:  Decorated pound cakes

FDA Issues Warning Letter to RTE Seafood Processor After Inspection and Poor Environmental Monitoring Results

FDA issued a Warning Letter to Harbor Marine Product Inc., Vernon, CA, a  processor of raw, ready-to-eat (RTE) fish.  FDA analysis found Listeria species (non-pathogenic strains) in the facility as well as identified many product handling issues that could lead to contamination of the RTE product.  

One takeaway from this is that Listeria is an food facility environmental hazard in sushi-grade RTE seafood.  This is one reason why the American College of Obstetricians and Gynecologists recommends that pregnant woman avoid all raw or undercooked fish.

FDA laboratory analysis found that (b)(4) of the (b)(4) environmental swabs were positive for non-pathogenic Listeria spp., including Listeria innocua, Listeria welshimeri, and Listeria grayi. Of the (b)(4) positive swabs, (b)(4)% ((b)(4) swabs) were collected from food contact surfaces in areas where raw, RTE salmon and tuna are processed. The positive food contact surfaces included:

• cutting board surface on fillet tables where raw, RTE salmon was touching;

• surfaces of tools, including pliers and knives, used to directly cut and manipulate raw, RTE salmon;

• table dividers, edges, and corners where raw, RTE tuna and salmon contacts;

• blade and handle of knife in ice bed used to cut raw, RTE tuna;

• water drain hole at the end of table where raw, RTE salmon is handled;

• cutting board surface of corner fillet table (where condensate was observed dripping from the air conditioning unit) where raw, RTE tuna and salmon contacts.

This demonstrates the facility's sanitation procedures have been inadequate to effectively control microbiological contamination in the facility. 

There were "numerous serious insanitary conditions and practices were observed in [the] facility during [the] FDA inspection."  Many of these issues would facilitate contamination of the RTE product with Listeria.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbor-marine-product-inc-710589-11282025
Harbor Marine Product Inc.
MARCS-CMS 710589 — November 28, 2025
Warning Letters

FDA Issues Warning Letters to Major Retailers for Failure to Remove Recalled Baby Formula

FDA issued Warning Letters to major retailers for failure to properly respond to the recall of ByHeart baby formula that was linked to botulism cases in infants.  Kroger, Walmart, Albertsons and Target were issued Warning Letter stating the the retailers did not properly conduct the needed corrective actions to remove product from the store shelves in a timely manner.  This is a reminder to entire industry for the need to properly respond to recall notices.

In a notice to the industry, FDA stated that inspectors "had checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. Through this effort, we found that recalled infant formula continued to be found on store shelves—for over three weeks in one case, in over 175 locations across 36 states."

Here are the highlights for the Warning Letter to Kroger.

• The Kroger Company (Kroger) was notified on November 8, 2025, of this voluntary recall. On November 11, 2025, ByHeart expanded the recall to all ByHeart Whole Nutrition Infant Formula, including all unexpired lots of formula cans and single-serve “anywhere pack” sticks. As a consignee of the recalled products, Kroger was notified in writing on November 11, 2025, that the scope of the voluntary recall had expanded to include all ByHeart infant formula products. Despite these recall notifications, subsequent visits by regulators confirmed that recalled ByHeart Whole Nutrition Infant Formula remained available for purchase on shelves at (b)(4) Kroger stores, including Kroger’s, King Sooper’s, and Smith’s, across 10 states well after the recall was initiated and subsequently expanded.
• However, based on FDA’s review of information from state and local partners, the Agency determined that recalled ByHeart Whole Nutrition Infant Formula remained on shelves at (b)(4) Kroger store locations across 10 states from November 12, 2025, to November 19, 2025. This represents a period of (b)(4) days after Kroger was first notified of the initial recall and (b)(4) days after Kroger was notified of the recall expansion
• On November 18, 2025, FDA held a call with you to discuss the ineffectiveness of the recall within your Walmart stores. During this discussion, FDA requested information regarding actions you were prepared to implement to ensure recalled product was no longer available for purchase at Walmart stores nationwide. Despite follow-up emails from the FDA on November 20, 21, and 24, 2025, and December 1, 3, and 8, 2025, you have not provided FDA with any information demonstrating that corrective actions to effectuate this recall have been implemented throughout your organization to prevent adulterated food from being received in interstate commerce and subsequently offered for sale.

Walmart, Albertsons and Target were issued similar letters with similar findings in failure to properly respond.

US Food and Drug Administration
https://content.govdelivery.com/accounts/USFDA/bulletins/4000713
FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula
U.S. Food and Drug Administration sent this bulletin at 12/15/2025 04:14 PM EST

Another Salmonella Outbreak Linked to Eggs in California

The California Dept of Health reported that 63 people have become ill with Salmonella Enteritidis infection from eggs from Vega Farms, Inc. in Dixon, CA.

According to one report, "After identifying the supplier of the suspect eggs, CDPH and CDFA conducted an inspection at Vega Farms, Inc. and collected egg and environmental samples for testing. Multiple samples tested positive for Salmonella. Whole genome sequencing analysis revealed that the Salmonella in at least one sample matched the strain found in sick individuals. Vega Farms eggs were sold to restaurants, grocery stores, co-ops, and in farmers markets in Northern California."

While no one likes to say it, Salmonella control is more difficult for operations with open range chickens.  Advise should be for cooking those eggs thoroughly.


https://www.independent.com/2025/12/12/cdph-warns-consumers-not-to-eat-recalled-vega-farms-inc-in-shell-eggs/

CDPH Warns Consumers Not to Eat Recalled Vega Farms, Inc. In-shell Eggs

By California Department of Public Health

Fri Dec 12, 2025 | 12:13pm

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FDA Provides Update on Infant Botulism Outbreak (12/10/25)

In the most recent update, CDC broadened the timeframe associated with the ByHeart product.  "CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022. As of December 10, 2025, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 19 states."

"Previously, case counts included illnesses from August 1, 2025, onward. With the expanded definition, CDC and state partners identified 10 additional prior cases that occurred from December 2023 through July 2025. At this time, no cases have been identified between March 2022 and December 2023. All 10 prior cases are confirmed infant botulism cases with documented exposure to ByHeart formula."

"FDA’s investigation is ongoing to determine the point of contamination."

Case Counts
Total Illnesses: 51 (12 New)
Hospitalizations: 51 (12 New)
Deaths: 0
Last Illness Onset: December 1, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally

The previous update was 12/3/25.

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.

Food Companies Push Back on Texas Law Requiring Warning Label for Certain Ingredients

Food companies are suing the State of Texas after the state's new law requiring warning labels for over 40 different ingredients.  "Section 9 of the law requires food manufacturers to include warning labels on products that include 44 listed ingredients, including artificial additives, dyes and chemicals, informing customers that governments in Australia, Canada, the European Union, or the United Kingdom have labeled the ingredients as “not recommended for human consumption.”"  Note, this is not based upon what the US has determined, but what other countries have determined.

From the Texas Rule

Sec. 431.0815.  FOOD CONTAINING ARTIFICIAL COLOR, ADDITIVES, OR CERTAIN BANNED CHEMICALS. (a) A food manufacturer shall ensure each food product the manufacturer offers for sale in this state includes a warning label disclosing the use of any of the following ingredients, if the United States Food and Drug Administration requires the ingredient to be named on a food label and the ingredient is used in a product intended for human consumption:

The warning label must:  (1)  include the following statement if the food contains an ingredient listed in Subsection (a), printed in a font size not smaller than the smallest font used to disclose other consumer information required by the United States Food and Drug Administration:

“WARNING: This product contains an ingredient that is not recommended for human consumption by the  appropriate authority in Australia, Canada, the European Union, or the United Kingdom.";

Many of these ingredients have been long used in the US and are in many of the foods we eat....well, foods I eat....you know, those highly processed foods like potato chips and snack cakes.

Here are some from the list which I knew to be readily used.

(Entire list - https://legiscan.com/TX/text/SB25/id/3247967  about half way down the webpage)

• Bleached flour is treated white flour treated creating a softer texture that absorbs more liquid, making it great for delicate cakes, cookies, and pie crusts
• BHA and BHT - synthetic antioxidants used as preservatives in foods (cereals, chips, meats, etc) to prevent fats and oils from going rancid
• Diacetyl occurs naturally and it gives butter its characteristic taste. Because of this, manufacturers of artificial butter flavoring, margarines or similar oil-based products typically add diacetyl to give that characteristic aroma/flavor.
• Potassium aluminum sulfate is a firming agent for pickles, leavening in baking, pH control
• Sodium aluminum sulfate is used in baking powder as a slow-acting leavening agent
• Sodium Lauryl Sulfate is an emulsifier/thickener in some dried eggs, marshmallows, and beverage bases
• Stearyl tartrate is an emulsifier and dough strengthener to improve dough texture
• Stearyl tartrate acts as a dough strengthener, emulsifier, and stabilizer in foods, improving consistency

To heck with the sugar in that pack of Ho-Hos, it is the dough conditioner you have to worry about.

Reuters
https://www.reuters.com/legal/government/food-industry-groups-sue-texas-over-ingredient-warning-labels-2025-12-08/
Food industry groups sue Texas over ingredient warning labels
By Dietrich Knauth

December 8, 20251:54 PM ESTUpdated December 8, 2025