Category: US Health

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 24, 2026
FDA Publish Date:
July 27, 2026
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description
Products were found to contain particulate matter

Company Name:
American Regent, Inc.
Brand Name:

Brand Name(s)
American Regent, Inc.

Product Description:

Product Description
Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL

Company Announcement
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde.
Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk. To date, American Regent, Inc. has not received any reports of adverse events related to this recall.
Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels, primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction. Papaverine Hydrochloride Injection, USP, is a clear, colorless pale-yellow solution and is available in a 2 mL single-dose vial containing 30 mg/mL
Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025. NDC, lot, expiration date and distribution dates can be found on the table below.
Product Description: Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vialNDC: 0517-4002-25Lot#: 25202Expiration Date: 11/30/2026Distribution Dates: 9/30/2025
American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products.
Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. This product is an intravenous injection and is to be used by or under the direction of a physician. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Contact Center
Contact Information
Area of Support

American Regent, Inc. Customer Service
Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM-4:00PM EST, Friday)
For detailed return/replacement/credit information

American Regent, Inc. Pharmacovigilance
Phone: 800-734-9236 Email: pv@americanregent.com
To report adverse events

American Regent, Inc. Product Quality Complaints
Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com
For product quality complaints

American Regent, Inc. Medical Information
Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com
For medical questions

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health.

Company Contact Information

Consumers:
(800) 645-1706

Product Photos

Content current as of:
07/27/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 24, 2026
FDA Publish Date:
July 24, 2026
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description
Particulate matter (cardboard) found in the solution.

Company Name:
Baxter International Inc.
Brand Name:

Brand Name(s)
Baxter

Product Description:

Product Description
Cefazolin in Dextrose Injection

Company Announcement
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard.
Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date, Baxter has not received any reports of adverse events related to this issue.
Affected Product:This product is used intravenously to treat bacterial infections or prevent them during surgery

Product Code
Product Description
Lot Number
Expiration Date
NDC Number

2G3508
Cefazolin in Dextrose Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix
LD175708
14-Feb-2027 
0338-3508-41

The affected lots can be identified by locating the lot number and expiration date on the front of the product package and the label attached to the carton, as shown in the images below.
The impacted product was distributed from 3/25/2025 to 6/30/2025 in the United States.
Customers should immediately discontinue use of and return all affected units in accordance with their facility’s process. Baxter is contacting customers with instructions on how to identify and return the impacted product.
For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The United States Food and Drug Administration (FDA) has been notified of this action.

Company Contact Information

Consumers:
(888) 229-0001

Product Photos

Content current as of:
07/24/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product

ENROUTE NPS

ENROUTE NPS Plus
The FDA is aware that Boston Scientific has issued a letter to affected customers recommending certain Percutaneous Catheter be removed from where they are used or sold.
Affected devices:

ENROUTE Transcarotid Neuroprotection System (NPS) 
ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus)

Full list of affected lots
What to Do
Do not use affected product. Identify affected product, cease use and distribution, and return to Boston Scientific. 
On July 9, Boston Scientific sent all affected customers a letter recommending the following actions:

Immediately stop further use or distribution and segregate affected product 
Return product to Boston Scientific 
Notify relevant personnel in your facility who use these devices
If any systems have been forwarded to another facility, contact that facility and provide them with the firm’s notice

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Boston Scientific stated they are initiating the removal of specific lots of ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus due to reports of arterial sheath tip separation or partial tip separation during use.
Tip separation may require endovascular or surgical retrieval of the retained tip. Complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis, or thrombosis. 
As of July 9, Boston Scientific has reported one serious injury and no deaths associated with this issue.
Device Use
The ENROUTE Transcarotid System is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. 
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCFieldActionCenter@bsci.com or call (763) 415-7708.
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. 

Content current as of:
07/24/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 24, 2026
FDA Publish Date:
July 24, 2026
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description
Presence of particulate matter identified as steel

Company Name:
Sunny Pharmtech, Inc.
Brand Name:

Brand Name(s)
Long Grove Pharmaceuticals

Product Description:

Product Description
Cyclophosphamide for Injection

Company Announcement
July 24, 2026 – Taoyuan City, Taiwan – Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this particulate matter issue have been reported.
Risk Statement: There is a reasonable probability for serious adverse events, including death, should a patient receive intravenous infusion of product found to contain particulate matter. For the population most at risk, cancer patients who are likely to have numerous pre-existing comorbidities and may be immunosuppressed due to concomitant or prior treatment and nutritional issues related to their cancer, complications can include phlebitis, granuloma, and occlusion or life-threatening thromboembolic events.
Cyclophosphamide for Injection, USP is indicated for treatment of malignant diseases (malignant lymphomas; Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma) and minimal change nephrotic syndrome in pediatric patients (biopsy-proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy).
The affected Product is packaged as 1 g/vial, one 50 mL single-dose vial in a carton (NDC 81298-8112-1) and as a 2 g/vial, one 100 mL single-dose vial in a carton (NDC 81298-8114-1). The affected product was distributed to wholesalers, distributors, hospitals and pharmacies from May 2024 to October 2024 and can be identified using the information below. The three recalled lots (C23019V1, C24015V1, V24010V1) will remain within expiry until October 2026, April 2027, and March 2027, respectively.

Product Name / Strength
Dosage Form / Package
NDC
Lot Number
Expiration Date

Cyclophosphamide for Injection, USP
1 g/vial, 50mL vial
81298-8112-1 
C23019V1 
Oct-2026 

Cyclophosphamide for Injection, USP 
 1 g/vial, 50mL vial
 81298-8112-1
C24015V1
Apr-2027

Cyclophosphamide for Injection, USP 
2 g/vial, 100 mL vial
81298-8114-1 
V24010V1 
Mar-2027 

Sunny PharmTech has notified FDA and its distributor, Cardinal Health, of this recall action and is coordinating with Long Grove Pharmaceuticals, LLC and Cardinal Health to notify pharmacies, hospitals, and other healthcare providers and to coordinate the return, reconciliation and destruction of the three lots of recalled product in accordance with the recall strategy.
Pharmacies, hospitals, and other healthcare providers that have the recalled product should immediately stop use and dispensing, and quarantine all affected product inventory, and follow the instructions in the recall notification for arranging return of the affected lots to Cardinal Health.
Consumers with questions regarding this recall may contact Sunny Pharmtech, Inc. at 886-3-4809168, Ext. 7205 or ra@sunnypharmtech.com, Monday through Friday from 9AM to 5PM GMT+8. Consumers should contact their physician or healthcare provider if they have experienced any problem that may be related to taking or using this drug product and should not stop or change prescribed treatment without consulting a healthcare professional.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting Program as follows:

This recall is being conducted with the knowledge of, and in coordination with, the U.S. Food and Drug Administration.

Company Contact Information

Product Photos

Source: US Department of Health and Human Services – 3

Kroger Large 12 eggs

P-1950 or 840962

011110609038

157 to 184

July 20 – August 17, 2026

Kroger Large 18 eggs

P-1950 or 840962

011110609335

157 to 184

July 20 – August 17, 2026

Kroger Large 60 eggs

P-1950

011110609144

157 to 184

July 20 – August 17, 2026

Kroger Extra Large 12 eggs

P-1950 or 840962

011110609045

157 to 184

July 20 – August 17, 2026

Kroger Medium 12 eggs

P-1950 or 840962

011110609021

157 to 184

July 20 – August 17, 2026

Kroger Medium 30 eggs

P-1950

011110609809

157 to 184

July 20 – August 17, 2026

Kroger Jumbo 12 eggs

P-1950 or 840962

011110609052

157 to 184

July 20 – August 17, 2026

Simple Truth Cage Free MediumBrown 12 eggs

P-1950

011110870230

157 to 184

July 20 – August 17, 2026

Simple Truth Cage Free LargeBrown 12 eggs

P-1950

011110797704

157 to 184

July 20 – August 17, 2026

Simple Truth Cage Free LargeBrown 18 eggs

P-1950

011110893109

157 to 184

July 20 – August 17, 2026

Simple Truth Cage Free LargeBrown 24 eggs

P-1950

011110150974

157 to 184

July 20 – August 17, 2026

Brookshire’s Large 12 Eggs

P-1950

092825095552

157 to 184

July 20 – August 17, 2026

Brookshire’s Large 18 Eggs

P-1950

092825095569

157 to 184

July 20 – August 17, 2026

Brookshire’s Large 36 eggs

P-1950

092825109808

157 to 184

July 20 – August 17, 2026

Brookshire’s Large 60 eggs

P-1950

092825095637

157 to 184

July 20 – August 17, 2026

Brookshire’s Large 6 eggs

P-1950

092825095644

157 to 184

July 20 – August 17, 2026

Brookshires Extra Large 18 Eggs

P-1950

092825095606

157 to 184

July 20 – August 17, 2026

Brookshire’s Jumbo 12 Eggs

P-1950

092825095583

157 to 184

July 20 – August 17, 2026

Country Morning Large 12 Eggs

P-1950

078566200004

157 to 184

July 20 – August 17, 2026

Country Morning Large 18 Eggs

P-1950

078566005036

157 to 184

July 20 – August 17, 2026

Country Morning Large 2 ½Dozen

P-1950

079307005162

157 to 184

July 20 – August 17, 2026

Country Morning Extra Large 12Eggs

P-1950

078566001021

157 to 184

July 20 – August 17, 2026

Country Morning Medium 12Eggs

P-1950

078566001045

157 to 184

July 20 – August 17, 2026

Country Morning Jumbo 12 Eggs

P-1950

078566001014

157 to 184

July 20 – August 17, 2026

Sunups Medium 2 1/2 Dozen

P-1950

028621304987

157 to 184

July 20 – August 17, 2026

Grade AA Large Bulk X 30DOZEN

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Large Bulk X 15 DOZEN

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Large Bulk – TICTAC

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Large Bulk – BROWN – TICTAC

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Medium Bulk X 30DOZEN

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Medium Bulk X 15DOZEN

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Extra Large Bulk X 15DOZEN

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Grade A Jumbo Bulk 20 eggs

P-1950

N/A

157 to 184

July 20 – August 17, 2026

Source: US Department of Health and Human Services – 3

For Immediate Release:
July 22, 2026

The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. The participating manufacturer intends to offer a device for use in providing care expected to be covered by the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model and intended to improve health outcomes for Americans managing certain chronic diseases.
“For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them.”
The FDA selected Dexcom, Inc., as the first participant in the TEMPO pilot. The Dexcom Glucose Health Program, which the FDA will continue to evaluate for its intended use during the pilot, is intended to address two clinical use areas in the ACCESS Model.
The Dexcom Glucose Health Program is intended to enable patients aligned to the ACCESS model and their healthcare professionals or caregivers to monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI insights for informed decision-making and behavioral modifications. The program is intended as an aid in the screening for prediabetes and type 2 diabetes through integrated digital health metrics. It may also contribute to improving glycemic control and lowering HbA1c in people with prediabetes.
“The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare,” said CMS Deputy Administrator and Director of the Innovation Center Abe Sutton. “ACCESS provides a clear payment pathway that rewards measurable improvements in patient health rather than individual services, while TEMPO helps generate the real-world evidence needed to evaluate promising new technologies responsibly.”
Manufacturers participating in the TEMPO pilot will collect, monitor, and report real-world data (RWD) relating to the intended uses of their devices to improve patient outcomes, whether the device is offered by the manufacturer itself as an ACCESS participant or by another participating ACCESS organization. The TEMPO pilot will help the FDA and CMS better understand how digital health technologies perform in real-world settings and how they may support efforts to improve care for people living with chronic diseases.
The FDA plans to select up to about ten TEMPO pilot participants in each of four ACCESS model clinical use areas who reflect a broad spectrum of manufacturers and are based in the United States. The FDA also intends to select participants in alignment with the TEMPO pilot’s strategic goals of promoting patient access, safeguarding patient safety, and generating meaningful RWD in connection with the ACCESS model. The FDA’s considerations include, among other things, potential risks to patient health, safety, or welfare; whether there is a reasonable expectation that the device could provide patient benefit; plans for RWD collection, monitoring, analysis, and reporting; and alignment with outcomes to be measured in the ACCESS model.
The FDA, in connection with the ACCESS model, launched the TEMPO pilot to align with the rapid and iterative nature of the development of digital health devices and expand patient access to innovative technologies for specific clinical use areas while safeguarding patient safety. The ACCESS model, whose first cohort began in July 2026, aims to expand access to new technology-supported care options, such as the use of devices selected for the TEMPO pilot, to help people improve their health and prevent and manage common chronic conditions, including certain cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
The FDA continues to consider statements of interest for participation in the pilot and intends to continue sending follow-up requests to certain potential pilot participants. There is no specified deadline for when the FDA will stop accepting statements of interest for participation in the TEMPO pilot.

Consumer:888-INFO-FDA

###

Boilerplate

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:
07/22/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

For Immediate Release:
July 22, 2026

The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. The FDA is issuing a final order revoking the authorized use of Orange B as a color additive in food and is proposing to revoke the authorized use of Citrus Red No. 2 as a color additive in food.
“The Trump Administration is taking decisive action to strengthen the safety of America’s food supply,” said Secretary of Health and Human Services Robert F. Kennedy, Jr. “By working to eliminate outdated authorizations for petroleum-based color additives that are no longer used, we are modernizing our food safety regulations and helping to Make America Healthy Again.”
The FDA is proposing to revoke the regulation authorizing the use of Citrus Red No. 2 as a color additive in food because the agency has tentatively concluded that its use has been abandoned by industry. Citrus Red No. 2 has been authorized since 1959 for coloring the skins of mature oranges.
“The FDA is committed to maintaining a science-based, modern regulatory framework that reflects current manufacturing practices and marketplace realities,” said Acting FDA Commissioner Kyle Diamantas, J.D. “By working to remove outdated and unnecessary authorizations under President Trump’s regulatory reform agenda, we are ensuring our regulations remain effective, transparent, and aligned with the agency’s public health mission.”
The FDA is also issuing a final order revoking the regulation authorizing the use of Orange B as a color additive in food. Following an evaluation of public comments on the proposed action, the agency did not receive information that changed its conclusion that the authorized use of Orange B has been abandoned by industry.
The FDA is accepting public comments on the proposed revocation of Citrus Red No. 2 as a color additive in food for 30 days. All comments must be submitted by August 24, 2026. Comments may be submitted electronically through the Federal eRulemaking Portal to docket FDA-2026-N-6304, or by mail to:
Dockets Management Staff (HFA-305)Food and Drug Administration5630 Fishers Lane, Room 1061Rockville, MD 20852
After reviewing the public comments, the FDA will determine whether to finalize the proposed revocation of Citrus Red No. 2.
These actions reflect the FDA’s ongoing commitment to reviewing and updating color additive regulations that are no longer relevant to current industry practices and represent significant milestones in the Administration’s broader effort to phase out petroleum-based color additives from the U.S. food supply. The FDA also continues to track voluntary industry commitments to remove petroleum-based food dyes from the food supply through its Tracking Food Industry Pledges to Remove Petroleum-Based Food Dyes webpage, which summarizes commitments from manufacturers, retailers, and trade associations as companies transition to alternative color sources and phase out petroleum-based food dyes.

Consumer:888-INFO-FDA

###

Boilerplate

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:
07/22/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 21, 2026
FDA Publish Date:
July 21, 2026
Product Type:
Food & Beverages
Reason for Announcement:

Recall Reason Description
Potential presence of soft plastic in the finished product.

Company Name:
PT Organics Limited
Brand Name:

Brand Name(s)
Pumpkin Tree Peter Rabbit Organics

Product Description:

Product Description
Banana & Strawberry Fruit Puree Pouches, 4 oz. (113 g)

Company Announcement
July 21st, 2026, PT Organics Limited of Lake Oswego, Oregon is voluntarily recalling select Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches because of an internal packaging defect that may result in the presence of a strand of soft, food-grade plastic in the finished product.
The recalled product was sold exclusively through Kroger, Meijer, and Target retail stores nationwide between 03/06/2026 and 07/13/2026.
The recalled Pumpkin Tree Peter Rabbit Organics Banana & Strawberry 4 oz. (113 g) pouches can be identified by the following codes, which are stamped in black ink on the back of the pouch:

Barcode: 8 15367 01078 0
Lane number – identified by the number ‘4’ printed on the rear right-hand side seam
Best-Before-Date (BBD) of 01/19/2027, 01/20/2027, 03/17/2027, 03/18/2027, 05/14/2027, or 05/15/2027.

No injuries have been reported. No other Pumpkin Tree branded products, best-before-dates, or flavors are affected by this recall.
PT Organics Limited initiated this voluntary recall after its packaging supplier last week recalled a production run of defective pouches. PT Organics’ inspections of finished product made with the recalled packaging confirmed the presence of a strand of a soft, food-grade plastic attached to the inside of a small number of pouches.
What to do if you have one of these products
PT Organics Limited encourages consumers and caregivers to check their products against the barcode, lane number and best-before-dates listed above.
Consumers or caregivers who have recalled product in their possession should dispose of it or return the product to the place of purchase. It should not be eaten or fed to another person.
Consumers with questions or concerns may visit our website www.pumpkintreesnacks.com or contact us via our consumer support desk at 888-566-2363, M-F, 8:00 am – 5:00 pm E.T. for more information.

Company Contact Information

Consumers:
Consumer Support Desk
888-566-2363

Content current as of:
07/21/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Baxter has issued a letter to affected customers recommending certain Duo-Vent solution sets be removed from where they are used or sold. 
Affected devices:

Product Code
Product Description
Lot Numbers
UDI-DI

1C8507
Duo-Vent Solution Set and Male Luer Lock Adapter. 10 drops/ mL.109″ (2.8 m). Sterile package
DR26C27062, DR26D14031, DR26E13055
00085412014319

What to Do
Do not use affected product. Immediately identify, quarantine, and return affected lots.
On June 30, Baxter sent all affected customers a letter recommending the following actions:

Immediately locate, isolate, and cease all use of the affected lot numbers of the product. The product code and lot number can be found on the individual product package and shipping carton. 
Contact Baxter Healthcare Center for Service to arrange for return and replacement product. 
If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product. 
Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, and any other departments within your institution who use the affected product. 
If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Baxter stated that certain lots of Duo-Vent solution sets may have air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
This issue may result in air entering the administration set when pressure is applied to the bag (e.g., via a pressure cuff) or when the tubing is flushed while fully open. If an infusion pump with an air-in-line detector is not in use—as may be the case during pressure infusions—there is a potential for air to be delivered through the IV line to the patient. 
In most cases, small amounts of air are absorbed in the lungs without causing harm. However, in patients with certain cardiac or vascular conditions (such as a patent foramen ovale or other right-to-left shunts), the presence of air in the circulation may lead to serious adverse events, including stroke, myocardial ischemia, or death.
As of July 15, Baxter has reported no serious injuries or deaths associated with this issue.
Device Use
The Duo-Vent solution set is used for the administration of fluids from a container into the patient’s vascular system through a vascular access device.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Baxter at (888) 229-0001.
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.

Content current as of:
07/20/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 19, 2026
FDA Publish Date:
July 19, 2026
Product Type:
Food & BeveragesFoodborne Illness
Reason for Announcement:

Recall Reason Description
Possible Salmonella Contamination

Company Name:
Relay Peak Research LLC dba Zen Principle Naturals
Brand Name:

Brand Name(s)
Zen Principle

Product Description:

Product Description
Moringa Leaf Powder Capsules

Company Announcement
Relay Peak Research LLC (Zen Principle Naturals) of Incline Village, NV is voluntarily recalling its Zen Principle® brand Moringa Capsules dietary supplement because the product has the potential to be contaminated with Salmonella, 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 product was distributed nationwide from December 2025 through July 2026, sold to consumers online primarily through Amazon.com and the company’s website, zenprinciple.com. Additionally, one unit was sold on eBay and one unit on Etsy.
The recalled product is Zen Principle® brand Moringa Capsules, 180 capsules packaged in a plastic bottle. The lot number (Lot A6FF4) and Best By date (11/2028) are printed on the bottom of the bottle. The product is offered as a 1-pack (180 capsules; Amazon code/FNSKU X000ZJJ4FT) and as a 2-pack (twin pack, 360 capsules; Amazon code/FNSKU X00159YJXP). No other products are impacted.
No illnesses have been reported to date.
The recall was initiated after the company was notified by its ingredient supplier that FDA testing of the moringa leaf powder used to manufacture the product returned positive for Salmonella. That raw material was used to produce this single lot of finished product. The company has ceased all sale and distribution of the product and is cooperating fully with the U.S. Food and Drug Administration.
Consumers who purchased Zen Principle® Moringa Capsules, Lot A6FF4, are urged to stop using the product and dispose of it. Consumers do not need to return the product to receive a full refund. To request a refund or ask any questions, consumers may contact the company at 775-451-6171 from 9 AM to 5 PM Pacific Time, or by email at info@zenprinciple.com.

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Content current as of:
07/19/2026

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