FDA and CDC Provide Update on Infant Botulism Cases Linked to Infant Formula (Nov 20, 2025)

FDA and CDC provided an update (Nov 20, 2025) on the investigation into infant botulism cases liked to infant formula.   As of November 20, 2025, there had been 31 reported cases with no reported deaths.

One issue of concern as stated in the FDA update was that product was still available for sale by some retailers.  Another concern was that some product was being sold online and shipped overseas where these people may not have been made aware.

The organism was found in the infant formula although its source had not yet been identified.  "As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third party laboratory analysis of some of these samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak. ByHeart states that it will continue to investigate these findings and perform ongoing testing to identify the source of contamination."

Case Counts
Total Illnesses: 31 (8 New)
Hospitalizations: 31 (8 New)
Deaths: 0
Last Illness Onset: November 13, 2025
States with Cases: AZ, CA, ID, IL, KY, ME, MI, MN, NC, NJ, OR, PA, RI, TX, WA
Product Distribution: Online and nationwide (including Guam and Puerto Rico)

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.

Product:
All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks.
ByHeart infant formula products makes up approximately 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

FDA and CDC Investigation into August Salmonella Outbreak Linked to Eggs Is Over

The FDA and CDC investigated illnesses in a multistate outbreak of Salmonella Enteritidis infections linked to large, brown, cage-free "sunshine/omega-3 golden” yolk eggs sourced from Country Eggs, LLC, of Lucerne Valley, CA.   The first notice was issued in August of 2025 and it is now reported that the outbreak is over and the investigation has been completed.  There were 105 reported cases from 14 states.  WGS analysis of environmental samples from the site matched the outbreak strains. 

"FDA initiated an inspection at Country Eggs, LLC, that included environmental sample collection. Of the samples collected, three of the environmental samples tested positive for Salmonella that matched the strain causing illnesses in this outbreak by whole genome sequencing (WGS) analysis."

"Based on epidemiological information collected by CDC, a total of 105 people infected with the outbreak strain of Salmonella have been reported from 14 states. Illnesses started on dates ranging from January 7, 2025, to August 14, 2025. 38 of 42 ill persons with information available reported exposure to eggs or an egg-containing dish before becoming ill. There have been 19 hospitalizations, and no deaths have been reported."

Case Counts
Total Illnesses: 105
Hospitalizations: 19
Deaths: 0
Last Illness Onset: August 14, 2025
States with Cases: AZ, CA, FL, GA, HI, IA, MN, NC, NE, NM, NV, NY, PA, WA
Product Distribution: CA, NV
*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-eggs-august-2025
Outbreak Investigation of Salmonella: Eggs (August 2025)
Outbreak is over. FDA’s outbreak investigation is complete.

Product:
On August 27, 2025, Country Eggs, LLC recalled large, brown, cage-free "sunshine/omega-3 golden” yolk eggs under the brand names Nagatoshi Produce, Misuho, Nijiya Markets, and Country Eggs.

This outbreak appears to be over. Product causing illness is no longer on the market.

NY Firm Recalls Dessert Buns For Improperly Designed Label Missing Milk Allergen

Prime Food Processing LLC of Brooklyn, NY is voluntarily recalling 2,243 cases of two dessert bun varieties because the packaging does not declare milk in the “Contains” allergen statement as required by the U.S. Food and Drug Administration (FDA). The milk in these products is derived from unsalted butter listed in the ingredient statement.  The issue was identified during an internal product review. The recall was initiated after it was discovered that packaging did not declare milk in the allergen statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s label review process.

The recalled products were distributed to Asian grocery stores between April 2, 2025 and November 14, 2025 in the following states:  AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prime-food-processing-llc-issues-allergy-alert-undeclared-milk-lava-bun-w-salted-egg-yolk-and-lava
PRIME FOOD PROCESSING LLC ISSUES ALLERGY ALERT ON UNDECLARED (MILK) IN LAVA BUN W/ SALTED EGG YOLK AND LAVA BUN WITH GREEN TEA FLAVOR
Summary
Company Announcement Date:  November 20, 2025
FDA Publish Date:  November 20, 2025
Product Type:  Food & Beverages  Allergens
Reason for Announcement:  Undeclared milk allergen
Company Name:  Prime Food Processing LLC
Brand Name:  Prime Food
Product Description:  Lava Buns

NY Distributor Recalls Cooking Pot After FDA Determines It Contains Leachable Lead

Shata Traders Inc of Brooklyn, NY is recalling Chef Brand Milk Pan 24 cm, because it has the potential to be contaminated with significant levels of lead (Pb) which may leach into food. FDA collected the product samples from a retail store, and the product analysis found the products contain leachable lead that is harmful for human consumption.

The Chef Brand Milk Pan 24 cm product was distributed in NY, NJ, CT, MD, VA and MA areas.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shata-traders-inc-recalls-chef-brand-milk-pan-24cm-because-possible-health-risk

SHATA TRADERS INC RECALLS CHEF BRAND MILK PAN 24cm BECAUSE OF POSSIBLE HEALTH RISK
Summary
Company Announcement Date:  November 19, 2025
FDA Publish Date:  November 19, 2025
Product Type:  Food & Beverages
Reason for Announcement: Product has the potential to be contaminated with significant levels of lead (Pb) which may leach into food
Company Name:  SHATA TRADERS INC
Brand Name:  Majestic Chef Pan
Product Description:  Milk Pan 24cm

Imported Strawberry Jam Recalled for Containing an Unapproved Color

Mangalm LLC of Newark, California, United States of America is recalling all /Tops Mixed Fruit Jam and Tops Strawberry Jam Products, because it contains carmoisine, (also know as FDA Red #10 and Azorubine.  It is designated E-122 in the EU) which is an unapproved color additive in the US.    The issue was discovered during an FDA inspection.  This product was imported from India, where the color is approved for use.

In an FDA background document:

Azorubine (carmoisine): This color was listed in 1939 as Ext. D&C Red No. 10 for

use in externally applied drugs and cosmetics and provisionally listed for these uses

in 1960, but was delisted in 1963 because no party was interested in supporting the

studies needed to establish safety. This color additive has never been approved by

FDA for use in food.

The color is approved for use in the EU, but must have a warning on the label indicating that  E122 could potentially increase symptoms of attention deficit hyperactivity disorder in children.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mangalm-llc-recalls-tops-mixed-fruit-jam-and-tops-strawberry-jam-product-because-possible-health
Mangalm LLC Recalls Tops Mixed Fruit Jam and Tops Strawberry Jam Product Because of Possible Health Risk
Summary
Company Announcement Date:  November 07, 2025
FDA Publish Date:   November 18, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Carmoisine
Company Name:  MANGALM LLC
Brand Name:  Tops
Product Description:  Mixed Fruit Jam and Strawberry Jam

Ohio Firm Recalls Mis-Formulated Ice Cream Bars with Allergen Concern

Jeni’s Splendid Ice Creams, Columbus, Ohio, is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy.  The recall was initiated after a crunch topping from a separate product was inadvertently introduced to this particular batch of Passion Fruit Dreamsicle Ice Cream Bars during manufacturing. The crunch topping contains wheat and soy, which is not declared on the packaging.

This is a case of mis-formulation with a post-process addition of the crunch topping containing the allergens. (The added allergens are bad enough, but nobody wants a crunch topping on their smooth-tasting passion fruit dreamsicle.  Just wrong.)

This product was distributed in grocery stores nationwide.  No illnesses or injuries have been reported to date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jenis-splendid-ice-cream-voluntarily-recalls-passion-fruit-dreamsicle-ice-cream-bars-due-undeclared
“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Summary
Company Announcement Date:  November 17, 2025
FDA Publish Date:  November 18, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen - soy, wheat.
Company Name:  Jeni’s Splendid Ice Cream
Brand Name:  Jeni’s
Product Description:  Passion Fruit Dreamsicle Ice Cream Bars

Congress Restricts Use of THC in Food

Over the past few years, we have seen a number of food products containing THC, especially beverages and gummies.  These products came about from a loophole in the 2018 Farm Bill that "that allowed hemp-derived products containing tetrahydrocannabinol, or THC to be sold."

Congress decided to close this loophole and enacts stricter rules to ban products with THC, and with this set a much lower limit for THC, the chemical that gives marijuana its psychological effects.  The bill will ban any products with more than 0.4 milligrams of THC.

USA TODAY
https://www.usatoday.com/story/news/nation/2025/11/15/hemp-loophole-familiar-products-could-be-banned/87249690007/
New law puts familiar drinks, creams and gummies in legal limbo
The provision closes a loophole that allowed hemp-derived products containing THC to be sold. Even products not marketed for their THC content may face legal problems.
Phaedra Trethan and Jeanine Santucci
November 15

The legislation to reopen the government also included strict new rules for hemp products that critics say threaten to outlaw mainstream drinks, creams, gummies, oils and vapes.

Oregon Creamery Recalls Cheese After FDA Testing Finds Listeria in Environment

Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes.  This recall is the result of an FDA environmental sample that identified the presence of Listeria monocytogenes in the processing area where this cheese was packaged. Finished product has not been tested positive for any contaminants.

The product was sold exclusively at Face Rock Flagship store in Bandon, Oregon.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/face-rock-creamery-llc-recalls-6oz-vampire-slayer-garlic-cheddar-because-possible-health-risk
Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
Summary
Company Announcement Date:  November 14, 2025
FDA Publish Date:  November 15, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Face Rock Creamery LLC
Brand Name:  Face Rock Creamery
Product Description:  Vampire Slayer Garlic Cheddar cheese

A Case of Toxic Squash Syndrome From Excessive Consumption of Gourd Juice

A Canadian woman became extremely ill suffering from toxic squash syndrome, or bitter bottle gourd poisoning" after consuming homemade juice from the calabash or bottle gourd.

After daily consumption of the juice, she was experiencing sudden weakness, nausea, vomiting, diarrhea and lower abdominal pain.  Medical tests "revealed that the woman's heart rate and breathing rate were high, and her blood pressure was initially high and then fell concerningly low. Her extremities were also unusually cool to the touch, indicating she had poor circulation. Meanwhile, one of the chambers of her heart was pumping very forcefully, and an echocardiogram suggested she was having other heart issues."  Internal investigation found her "stomach lining was inflamed and bleeding as a result of tissue damage, which was likely caused by poor oxygen delivery to the tissue."

The issue was the level of cucurbitacins.  An AI entry provides that these are "bitter-tasting chemical compounds found in plants of the Cucurbitaceae family (like cucumbers, melons, and squash), which protect wild plants from predators. While they can be toxic in high concentrations, especially in wild or improperly cultivated varieties, domesticated plants are bred to have low levels. Research indicates that cucurbitacins have potential medicinal uses, such as anti-inflammatory, antioxidant, and anticancer properties, but further research is needed to evaluate safety and efficacy. "

Why would she consume this?  Evidently, cucurbitacins have potential health benefits including ani-cancer, anti-inflammatory, liver health, hair growth, and anti-diabetic.  But this is 'potential' in that they are not fully understood, especially regarding dosage.  And controlled dosage can be difficult to manage when someone is just pureeing these at home in their food processor and consuming every day.  A good message to remember here is, "to live by the gourd, is to die by the gourd".


Live Science
https://www.livescience.com/health/food-diet/diagnostic-dilemma-a-womans-homemade-juice-led-to-life-threatening-toxic-squash-syndrome
Diagnostic dilemma: A woman's homemade juice led to life-threatening 'toxic squash syndrome'

Features

By Nicoletta Lanese published November 12, 2025