Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set

Source: US Department of Health and Human Services – 3

The affected products and recommendations for what to do with the devices below have not changed.
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product

The FDA is aware that Hamilton Medical has issued a letter to affected customers recommending certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators have updated use instructions.
Affected devices:

Product Name

Brand Name

Product Number

UDI-DI

T1 CIRCUIT 240 +VALVE B/10

Hamilton Breathing circuit sets, coaxial

260127

07630002802956

T1 CIRCUIT 180 +VALVE B/20

Hamilton Breathing circuit sets, coaxial

260128

07630002802963

MR1 CIRCUIT 300 +VALVE B/10

Hamilton Breathing circuit sets, coaxial

260167

07630002802970

MR1 CIRCUIT 480 +VALVE B/8

Hamilton Breathing circuit sets, coaxial

260168

07630002802987

Full List of Affected Lots
What to Do
Users should review and follow the pre-operative test instructions and troubleshooting instructions prior to continued use.
On May 18, 2026, Hamilton Medical sent all affected customers a letter recommending the following actions:

Verify unimpeded expiratory gas flow prior to use by ventilating a test lung using the settings provided by Hamilton Medical after performing the pre-operative test.

If no “exhalation obstruction” alarm is issued, the expiratory valve is safe to use.
If the “exhalation obstruction” alarm is triggered, do not use the coaxial breathing circuit set. The coaxial breathing circuit set must be discarded and replaced.

If the “Exhalation Obstructed” alarm is triggered on the ventilator, users should perform the following steps:

Disconnect the patient from the ventilator and ensure alternative means of ventilation (e.g. alternative ventilator, hand bagging, etc.).
Once patient safety is ensured, remove the expiratory valve set and overcome the membrane adhesion by detaching the membrane from the expiratory valve body once.
Place the membrane back onto the body. Then, ensure the membrane is aligned with the expiratory valve body with the metal facing up (do not press onto the metal) and install the expiratory valve set into the exhaust port on the ventilator.
Alternatively, use a new expiratory valve set.

Inform all potential users of affected coaxial breathing circuit sets about this issue and post the provided notice in your facility. Make sure recommended actions are followed.
Affected products may continue to be used with the risk mitigations provided above.

Reason for Correction
Hamilton Medical stated that certain lots of coaxial breathing circuit sets preassembled with an expiratory valve set do not perform as intended. In some cases, the expiratory valve membrane adhered to the sealing ring on the body of the expiratory valve, impairing valve opening and expiratory gas flow. The issue is not detected during the pre-operative test of the ventilator unless a test lung is actively ventilated. If the expiratory valve membrane is adhered to the sealing ring, the malfunction appears within the first breaths after ventilation is initiated.
When the expiratory gas flow is impeded, the end-expiratory pressure is too high, or the end-expiratory flow is too low. This will trigger the ventilator’s “Exhalation Obstructed” alarm.
An obstruction of expiratory flow results in inadequate ventilation and impaired gas exchange. Acute respiratory compromise due to impaired exhalation may result in inadequate ventilation and oxygen desaturation (hypoxemia).
As of May 13, Hamilton Medical has reported four serious injuries and no deaths associated with this issue.
Device Use
Hamilton Medical, Inc. ventilator coaxial breathing circuits are intended to connect HAMILTON-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Hamilton Medical at complaints@hamiltonmedical.com or call 1-800-426-6331.
Additional FDA Resources  

FDA Enforcement Report
CDRH Medical Device Recall Database

Unique Device Identifier (UDI)  
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates

Date
Actions

07/02/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.

06/08/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. 

Content current as of:
07/02/2026

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Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (CMS-1850-P)

Source: US Department of Health and Human Services

Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (CMS-1850-P)

On July 2, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies and rates for hospital outpatient and Ambulatory Surgical Center (ASC) services under the Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule for calendar year (CY) 2027. CMS is publishing this proposed rule consistent with the legal requirements to update Medicare payment policies for hospital outpatient and ASCs annually. This fact sheet discusses the proposed rule’s major provisions.

CMS Acts to Strengthen Care Quality, Cut Drug Costs, and Slash Out-of-Pocket Expenses for Medicare Beneficiaries

Source: US Department of Health and Human Services

CMS Acts to Strengthen Care Quality, Cut Drug Costs, and Slash Out-of-Pocket Expenses for Medicare Beneficiaries

In a move aimed at reshaping how Medicare pays for certain outpatient care services, the Centers for Medicare & Medicaid Services (CMS) today announced a proposed rule that would revise payment policies and rates for hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs) beginning in Calendar Year (CY) 2027 — signaling a renewed federal push to lower costs for Medicare beneficiaries, safeguard taxpayer investments, and strengthen access to high-quality care across the country.

Kao USA Voluntarily Recalls Some Lots of Oribe Serene Scalp Densifying Shampoo

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 01, 2026
FDA Publish Date:
July 01, 2026
Product Type:
Cosmetics
Reason for Announcement:

Recall Reason Description
May be contaminated with Pluralibacter gergoviae bacteria

Company Name:
KAO USA
Brand Name:

Brand Name(s)
Oribe

Product Description:

Product Description
Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz)

Company Announcement
Select units of Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) affected
CINCINNATI–(BUSINESS WIRE)–Kao USA Inc. (“Kao USA”) today issued a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to the detection of Pluralibacter gergoviae bacteria.
Though Pluralibacter gergoviae bacteria pose little medical risk to healthy people, those with certain health issues such as weakened immune systems may be more susceptible to infection by the bacteria. Regardless of health status, Kao USA is urging anyone who has affected products as specified below to discontinue use.
The recall is limited to specific lots of the Oribe Serene Scalp Densifying Shampoo in8.5 oz and 33.8 oz sizes. Further investigation to confirm the scope of the issue is still ongoing.
Identifying the Affected Products:

Oribe Serene Scalp Densifying Shampoo (in 8.5 oz and 33.8 oz sizes), manufactured between February 21, 2026 and February 26, 2026, could be impacted.
The affected lot codes for the 8.5 oz size (UPC 840035231242) can be found onthe bottom of the bottle printed in black and begin with the prefix “YR”: o YR010556
The affected lot codes for the 33.8 oz size (UPC 840035231273) can be found onthe bottom of the bottle printed in black and begin with the prefix “YR”: o YR010566 o YR010576

To report any adverse events experienced with the use of this product, arrange for a replacement or for any questions, please contact the Kao Professional Hair Technical Hotline at 800-333-2442 or email oribecomplaints@kao.com.
We are working with the FDA to voluntarily recall the affected lots of the product in question from our warehouses. We are also asking retail and salon partners to remove affected lots from use and/or sale and return them to us for safe disposal.
At Kao USA, the safety of our products and consumers is our highest priority. We are working with our partners to review manufacturing practices to help prevent similar issues in the future.
###
Kao USA Inc. manufactures premium beauty care brands that are sold around the world. Founded in 1882, Kao USA Inc. is a wholly owned subsidiary of Kao Corporation.
Contacts
Press Queries: Molly Killen, molly.killen@kao.comTechnical or Regulatory Queries: Keisha Ringo, keisha.ringo@kao.com

Company Contact Information

Consumers:
Kao Professional Hair Technical Hotline
800-333-2442

Content current as of:
07/01/2026

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Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 01, 2026
FDA Publish Date:
July 01, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
Undeclared allergen – wheat, soy, sesame

Company Name:
Eunha Fisheries Co., Ltd
Brand Name:

Brand Name(s)
Eunha Fisheries Co., Ltd

Product Description:

Product Description
Sliced Korean Halibut and Flounder Sashimi products

Company Announcement
July 01, 2026 EUNHA FISHERIES CO., LTD., Busan, Republic of Korea, is recalling certain Sliced Korean Halibut and Flounder Sashimi products because the accompanying soy sauce and vinegar red pepper paste packets contain wheat, soy, and sesame that were not declared in English on the individual condiment packets.
People who have an allergy or severe sensitivity to wheat, soy, or sesame run the risk of serious or life-threatening allergic reactions if they consume these products.
The affected products were distributed in the United States through WOOLTARI USA Inc. and JAYONE FOODS, Inc. Products reached consumers through retail stores, direct delivery, wooltariusa.com online website.
The recalled products can be identified as follows
– PRODUCT NAME: Sliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste

Best Before Date: 2026.05.07
Package: Fish-shaped plastic tray with paper sleeve
Included Condiment Packets: Soy Sauce, Vinegar Red Pepper Paste, Wasabi
Undeclared Allergens: Soy, Wheat
UPC CODE : 6 78108 16991 4
NET WEIGHT : 12.2OZ(347g)
KEEP FROZEN
PACKING SIZE : 38*20(cm)

– PRODUCT NAME : Sliced Korean Halibut with Soy Sauce, Wasabi, Vinegar Chili Paste

Best Before Dates: 2026.07.11 and 2026.12.08
Package: Fish-shaped plastic tray with paper sleeve
Included Condiment Packets: Soy Sauce, Vinegar Red Pepper Paste, Wasabi
Undeclared Allergens: Soy, Wheat, Sesame
EAN-13 CODE : 8 809342 366186
NET WEIGHT : 300g
KEEP FROZEN
PACKING SIZE : 38*20(cm)

PRODUCT FLOUNDER SASHIMI WITH SAUCE
No illnesses have been reported to date in connection with these products.
The recall was initiated after it was determined that the accompanying soy sauce and vinegar red pepper paste packets contained allergens that were not declared in English on the individual condiment packets. Although the allergens were declared on the outer package, they were not identified on the individual condiment packets.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have purchased these products and have an allergy or sensitivity to wheat, soy, or sesame should not consume the products. Consumers are urged to discard the products or return them to the place of purchase.
Consumers with questions may contact:
EUNHA FISHERIES CO., LTD.
Telephone: +82-51-831-1622Email: hyeonjung.min@eeunha.com
Hours of Operation:Monday through Friday 7:00 pm to 4:00 am (GMT-4)4:00PM to 1:00 am (GMT-7)

Company Contact Information

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Content current as of:
07/01/2026

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CMS Launches Medicare GLP-1 Bridge, Expanding Access to GLP-1 Medications

Source: US Department of Health and Human Services

CMS Launches Medicare GLP-1 Bridge, Expanding Access to GLP-1 Medications

Eligible Medicare beneficiaries may now get certain GLP-1 medications for $50 per month through the Medicare GLP-1 Bridge, a new Centers for Medicare & Medicaid Services (CMS) initiative designed to expand access to innovative treatments and test the impacts of increased access to GLP-1 drugs for weight management on the Medicare program. 

FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

Source: US Department of Health and Human Services – 3

For Immediate Release:
June 30, 2026

The U.S. Food and Drug Administration today approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). It represents a novel approach to allogeneic hematopoietic stem cell transplantation in some adult patients with high-risk blood cancers. It addresses an important unmet need in transplantation, where curing the cancer is often only part of the challenge; avoiding chronic GVHD is equally important for long-term outcomes.
Tregzi uses stem cells and immune cells collected from blood of a closely matched donor to help the body fight cancer while reducing the risk of a serious complication called chronic GVHD — a condition that can occur when transplanted donor blood cells attack the patient’s body. Patients receive this treatment after undergoing chemotherapy to prepare their bodies for a bone marrow or stem cell transplant.
“For patients with blood cancers who need stem cell transplantation, chronic graft-versus-host disease has long been one of the most feared and difficult-to-prevent complications,” said Karim Mikhail, B.Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “Today’s approval offers a genuine new approach that can help reconstitute the immune system while substantially reducing that risk and reflects the promise of what cellular therapy can deliver for patients.”  
Tregzi is a donor-derived cellular immunotherapy composed of three cell components: purified hematopoietic stem and progenitor cells (HSPCs), Treg cells, and conventional T (Tcon) cells, each derived from the mobilized peripheral blood of an 8/8 HLA-matched related or unrelated donor. Treg cells are a type of immune cell that help regulate immune responses and maintain immune tolerance. Tregzi is designed to reduce the risk of chronic GVHD during reconstitution of the patient’s blood-forming and immune systems.  
The safety and effectiveness of Tregzi were established through PRECISION-T, a clinical trial in which 187 adult patients with blood cancers, including acute leukemia and myelodysplastic syndrome, were randomly assigned to receive either Tregzi or a standard stem cell transplant. The primary endpoint was chronic GVHD-free survival, defined as the time from HSCT to the earliest occurrence of either death from any cause or the first onset of moderate or severe cGVHD, within two years after day 0. Patients who received Tregzi achieved significantly higher rates of chronic GVHD-free survival. At one year, 78% of patients who received Tregzi achieved this outcome, compared to 38.4% of patients who received a standard transplant. After accounting for death as a competing risk, 12.6% of patients who received Tregzi developed serious chronic GVHD within one year, compared with 44% of patients who received a standard transplant. The highly persuasive and internally consistent results from this randomized controlled trial denote clinical benefit in the indicated population. The FDA reviewed the results of this trial and determined that the benefits of Tregzi outweigh its risks.  
The side effects observed with Tregzi were generally consistent with those expected in patients undergoing stem cell transplantation — most commonly, infections. No patient had a severe reaction during the infusion of Tregzi, and no cases of graft failure were observed within the study period. Patients and health care professionals should review the full prescribing information for complete safety information.
The application was granted Orphan Drug and Regenerative Medicine Advanced Therapy designations.
The FDA granted approval of Tregzi to Orca Biosystems, Inc.

Consumer:888-INFO-FDA

###

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Content current as of:
06/30/2026

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FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing

Source: US Department of Health and Human Services – 3

Today, the U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.
The FDA launched the PreCheck Pilot Program on February 1, 2026, in response to Executive Order 14293 signed by President Trump in May 2025 and following a public meeting on challenges and opportunities to facilitate domestic manufacturing. The pilot program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market, helping support greater access to critical medicines for Americans.
“President Trump is rebuilding America’s pharmaceutical manufacturing base because our nation’s health and security depend on it,” said HHS Secretary Robert F. Kennedy Jr. “The FDA’s PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the United States, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines. This is another important step toward making America healthier, stronger, and more self-reliant.”
Between February 1 and March 1, 2026, the FDA received over 80 requests to participate in the FDA PreCheck Pilot Program. To be eligible, companies proposed a new domestic manufacturing facility that will be capable of manufacturing drug products to address a market supply need or improve patient access to therapies for unmet medical needs. Eligible companies also committed to submitting a New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), or a supplement to one of those applications that relies on the new manufacturing facility.
FDA drug and biologic experts evaluated all requests to participate using an objective framework and scoring rubric. In evaluating the requests, the FDA considered several aspects including the products to be manufactured, the stage of facility development, the anticipated timeline for bringing products to the U.S. market, and innovation in facility development and manufacturing operations.
”This milestone reflects the Trump administration’s commitment to strengthening domestic pharmaceutical manufacturing capacity, creating American jobs, and driving down drug costs for families. It further highlights the value of early FDA engagement in building a more resilient U.S. drug supply chain and reducing reliance on foreign sources of pharmaceutical production,” said Acting FDA Commissioner Kyle Diamantas, J.D. “By making our regulatory processes and expectations more transparent, we ensure that American pharmaceutical manufacturers remain global leaders while securely providing high-quality treatments to patients right here at home.”
The following companies have been selected to participate in the pilot:

Amneal Pharmaceutical: Amneal’s facility in Long Island, NY will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases.
Cellares Corp.: Cellares’s facility in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases.
Eli Lilly and Company: Eli Lilly’s facility in Lebanon, IN will manufacture drug substance (active pharmaceutical ingredients) in support of the company’s existing and future medicines.
FUJIFILM Biotechnologies:FUJIFILM’s facility in Holly Springs, NC will support commercial-scale cell culture biomanufacturing.
Kriya Therapeutics, Inc.: Kriya’s facility in Durham, NC will manufacture AAV-based gene therapy products to address chronic disease conditions.
Kyowa Kirin, Inc.: Kyowa’s facility in Sanford, NC will manufacture biotechnology drug substance for rare diseases.
Regeneron Pharmaceuticals, Inc.: Regeneron’s facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases.

Selected participants will engage with FDA under the two-phase PreCheck model. In  Phase 1 (Facility Readiness), participants will receive early technical guidance from the FDA before the facility becomes operational, including reviews of facility information submitted through a facility-specific Drug Master File (DMF). This allows the FDA to assess and help enhance facility readiness before a drug or biologics application is submitted. In  Phase 2 (Application Submission), participants will have opportunities for enhanced engagement with the FDA through facility-focused pre-submission meetings, which are intended to support expedited facility evaluation and enable inspections earlier in the review cycle.
The FDA PreCheck Pilot Program enhances FDA-industry engagement by facilitating earlier interactions to minimize uncertainty associated with manufacturing readiness. The PreCheck model enables FDA expertise and feedback to inform the acceleration of the facility development process from the outset, while allowing the FDA to identify potential facility issues before they result in deficiencies that could delay or prevent application approval. By facilitating earlier resolution of manufacturing issues, the program is intended to support the timely availability of critical drugs for Americans.
FDA will continue to evaluate implementation of the PreCheck Pilot Program and assess opportunities to inform future program development.
For more information visit the FDA PreCheck Pilot Program webpage .

Consumer:888-INFO-FDA

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

La Ceiba Foods Latin Market Inc. Recalls Cottage Cheese Products Because of Possible Health Risk

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 26, 2026
FDA Publish Date:
June 26, 2026
Product Type:
Food & BeveragesFoodborne Illness
Reason for Announcement:

Recall Reason Description
Potential to be contaminated with Listeria monocytogenes

Company Name:
La Ceiba Foods Latin Market Inc.
Brand Name:

Brand Name(s)
La Colonia, Selectos Latinos, Clover Hill

Product Description:

Product Description
Soft Ricotta Cheese, Mexican Cottage Cheese

Company Announcement
June 26, 2026, – La Ceiba Foods Latin Market Inc. is conducting a recall of Requesón Salvadoreño (Salvadoran Cottage Cheese) and Requesón Mexicano (Mexican Cottage Cheese) products marketed under the La Colonia and Selectos Latinos brands, due to possible contamination with Listeria monocytogenes. Listeria monocytogenes is a bacterium that can cause serious and sometimes fatal infections in young children, older adults, pregnant women, and people with weakened immune systems. Healthy people may have short-lived symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also lead to miscarriages and stillbirth in pregnant women.
The affected products were distributed to supermarkets, retail stores and restaurants in the states of Maryland, Virginia and Washington, D.C.
La Ceiba Foods recalls the below identified affected products from the market. This recall includes all lots/batches within expiry.

Brand

Product

UPC

Size

Date of Distribution

EXP Date

La Colonia

Salvadoreno Requeson,Soft Ricotta Cheese

736846383099

14 oz

05/11/2026-06/01/2026

07/10/2026

SelectosLatinos

Requeson Salvadoreno,Ricotta Style SalvadoreanStyle Cheese

767787984526

16 oz

05/11/2026-06/01/2026

07/10/2026

SelectosLatinos

Requeson Mexicano,Mexican Cottage Cheese

767787984519

16 oz

05/11/2026-06/01/2026

07/10/2026

Clover Hill

Buket of Requeson

 

18 lb

05/11/2026-06/01/2026

07/10/2026

This recall was initiated after La Ceiba Foods was notified of a recall action by its supplier, Clover Hill Dairy, following the identification of possible contamination with Listeria monocytogenes in products manufactured at the facility. Additionally, the FDA and CDC, in collaboration with state and local partners, are investigating a multi-state, multi-year outbreak of Listeria monocytogenes infections linked to requeson, a soft cheese like ricotta, manufactured by Clover Hill Dairy, LLC of Mechanicsville, MD. Twelve illnesses and one death have been reported to date.
Consumers are advised not to consume, sell, or serve the recalled products. Products must be returned to the place of purchase for a full refund.
Consumers with questions can contact the Southern Maryland Agricultural Development Commission, on behalf of Clover Hill Dairy, at 240-528-8850 extension 327, Monday through Friday, 8:00 a.m. to 4:30 p.m. (Eastern time).
La Ceiba Foods sincerely regrets any inconvenience this recall may cause its customers and reaffirms its commitment to food safety and the quality of its products. The company continues to work closely with its suppliers and regulatory authorities to ensure the safety of the products it distributes.
Link to FDA Advisory

Company Contact Information

Consumers:
Southern Maryland Agricultural Development Commission
240-528-8850 extension 327

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Content current as of:
06/26/2026

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Total Nutrition Inc. Recalls Organic Moringa Products Following Supplier-Initiated Recall Due to Possible Health Risk

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 26, 2026
FDA Publish Date:
June 26, 2026
Product Type:
Food & BeveragesFoodborne Illness
Reason for Announcement:

Recall Reason Description
Possible Salmonella Contamination

Company Name:
Total Nutrition Inc.
Brand Name:

Brand Name(s)
TNVitamins

Product Description:

Product Description
TNVitamins 100% Organic Moringa Capsules and Powder

Company Announcement
Total Nutrition Inc. of Deer Park, NY is voluntarily recalling TNVitamins 100% Organic Moringa 1,200 mg Capsules and 100% Organic Moringa Powder following a supplier-initiated recall of the raw Organic Moringa ingredient because of possible Salmonella exposure. No illnesses have been reported to date.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
The recalled product was distributed nationally through the online platforms, Amazon, Walmart, TikTok Shop, and Target, as well as the company’s website, http://www.tnvitamins.com/.
The following lots are included in the recall:

Product

Product #:

Lot #:

Expiration:

TNVitamins 100% Organic Moringa Capsules 1,200 mg

AB9917

Lot #: 2800

Exp: 2/2028

TNVitamins 100% Organic Moringa Powder

AB9904

Lot #: 2782

Exp: 5/2028

The lot numbers are located on the bottom of the bottle as well as near the barcode on the label. If your lot does not match one of the lots listed above, it is not affected by this recall.
The TNVitamins 100% Organic Moringa 1,200 mg Capsules product is packaged in a white HDPE supplement bottle with a smooth white cap containing 90 clear capsules filled with green organic moringa powder. The TNVitamins 100% Organic Moringa Powder product is packaged in a white HDPE jar with a smooth white cap containing 96 grams of green organic moringa powder.
Customers who have purchased the affected products are asked to dispose of them immediately. Do not eat, sell, or serve the product. For more information, please visit http://tnvitamins.com/organic-moringa-recall.
We apologize for the inconvenience and concern this recall may cause to our customers. For questions, please reach out to customerservice@tnvitamins.com. TNVitamins is committed to ensuring the quality of our products and the well-being of our consumers.

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Content current as of:
06/26/2026

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