FDA News & Updates

Latest safety alerts, press releases, and recalls from the FDA

MedWatch Safety Alerts
Yesterday

Glucose Monitor Sensor Recall: Abott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings

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MedWatch Safety Alerts
Yesterday

Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

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MedWatch Safety Alerts
2 days ago

Early Alert: Heart Pump Issue from Abiomed

The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.

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FDA Press Releases
3 days ago

FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing

The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program.

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FDA Recalls
1 weeks ago

Why Not Natural, Houston, Texas, is Recalling its Why Not Natural Organic Moringa - Green Superfood because of Possible Health Risk

Why Not Natural, Houston, Texas, is voluntarily recalling its Why Not Natural Organic Moringa - Green Superfood because they may 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 im

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FDA Recalls
1 weeks ago

Akkarco LLC Recalls Product Due to Possible Health Risk

Akkarco LLC of Lorton, Virginia, is voluntarily recalling Ashfiat Alharamain Energy Support because the product contains undeclared Tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE5) inhibitors. Produc

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FDA Recalls
1 weeks ago

Neogen Issues Voluntary Nationwide Recall of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution

LANSING, Mich. – (BUSINESS WIRE) – Neogen Corporation (NASDAQ: NEOG) is voluntarily recalling all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level. Neogen distributes this product, which is manufactured by a th

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FDA Recalls
1 weeks ago

Koikoi Trading Inc., Issues Allergy Alert on Undeclared Wheat and Sesame in FU ZHOU FISH BALL (200g / 400g / 5lb)

Commerce, CA – Koikoi Trading Inc. is recalling certain lots of FU ZHOU FISH BALL products in multiple pack sizes (200g, 400g, and 5LB) because the products may contain undeclared allergens: wheat and sesame. People who have an allergy or severe sensitivity to wheat and/or sesame run the risk of a s

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FDA Recalls
1 weeks ago

Gerber Products Company Announces Voluntary Recall of Limited Batches of Arrowroot Biscuits Out of an Abundance of Caution Due to Potential Presence of Foreign Material Following Supplier Recall

January 26, 2026 — Gerber Products Company is initiating a voluntary recall of limited batches of Gerber® Arrowroot Biscuits out of an abundance of caution due to the potential presence of soft plastic and/or paper pieces that should not be consumed. The material comes from an arrowroot flour suppli

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FDA Recalls
1 weeks ago

Navitas Organics Voluntarily Recalls Select Lots of 8oz Organic Chia Seeds Because of Possible Health Risk

Navitas Organics is voluntarily recalling select lots of its 8oz Organic Chia Seeds due to possible Salmonella contamination. This recall is being conducted as a precautionary measure following a recall initiated by the company’s chia seed supplier.

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FDA Recalls
1 weeks ago

IKM Recalls Product Because of Possible Health Risk

IKM of San Jose, California is recalling the following cookware items because they may be contaminated with significant levels of lead (Pb) which may leach into food.

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MedWatch Safety Alerts
2 weeks ago

Early Alert: Insufflation Unit Issue from Olympus

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.

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MedWatch Safety Alerts
2 weeks ago

Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences

Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers

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FDA Press Releases
2 weeks ago

FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry

The U.S. Food and Drug Administration today announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imported products.

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FDA Press Releases
2 weeks ago

FDA Takes Steps to Improve Gluten Ingredient Disclosure in Foods

Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.

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FDA Recalls
2 weeks ago

Tri-Union Seafoods Identifies Additional Quantities of Recalled Genova® Tuna at Limited Retailers Due to Inadvertent Distribution of Previously Recalled Product

El Segundo, CA, January 16, 2026 – Tri-Union Seafoods is cautioning consumers that a third-party distributor inadvertently released quarantined product that was associated to a February 2025 recall. The initial voluntary recall was conducted following notification from our supplier that the “easy op

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FDA Recalls
2 weeks ago

Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during

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MedWatch Safety Alerts
2 weeks ago

Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.

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MedWatch Safety Alerts
2 weeks ago

Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers

Draeger is removing certain Vapor 2000 and Vapor 3000 Vaporizers due to impurities found within a component.

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MedWatch Safety Alerts
2 weeks ago

Early Alert: Broselow Rainbow Tape Issue from AirLife

AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.

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MedWatch Safety Alerts
2 weeks ago

Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits

Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing.

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FDA Recalls
2 weeks ago

Superfoods Inc. dba Live it Up. Recalls Live it Up Super Greens Because of Possible Health Risk

Superfoods Inc. DBA as Live it Up of New York, New York is recalling all Live it Up Super Greens, including both Original and Wild Berry flavors, with lots beginning with the letter “A” and all stick pack products due to possible contamination with Salmonella, an organism which can cause serious and

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MedWatch Safety Alerts
3 weeks ago

Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

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FDA Recalls
3 weeks ago

Spring & Mulberry Expands Voluntary Recall of Select Chocolate Bars Due to Possible Salmonella Contamination

Raleigh, North Carolina (January 14, 2026) — Spring & Mulberry is updating their press release previously issued on January 12, 2026, to expand their voluntary recall beyond Mint Leaf to include additional flavors (see table below), due to possible contamination with Salmonella.

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MedWatch Safety Alerts
3 weeks ago

Early Alert: Dialysis Tubing Set Issue from Vantive

Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use.

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FDA Recalls
3 weeks ago

VH Foods Inc. DBA Outside The Breadbox Issues Allergy Alert on Undeclared Egg and Milk in "Bread Crumbs"

January 12, 2026, VH Foods Inc. DBA Outside The Breadbox of Colorado Springs, CO is recalling its 8 ounce packages of "Bread Crumbs" because they may contain undeclared egg and milk

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FDA Press Releases
3 weeks ago

FDA Approves First Treatment for Children With Menkes Disease

The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.

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FDA Recalls
3 weeks ago

Spring & Mulberry Issues Voluntary Recall of Mint Leaf Date Sweetened Chocolate Bar Due to Possible Salmonella Contamination

Raleigh, North Carolina (January 12, 2026) — Spring & Mulberry is voluntarily recalling lot #025255 of its Mint Leaf Date Sweetened Chocolate Bar (2.1 oz) due to possible contamination with Salmonella.

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FDA Recalls
3 weeks ago

Food Business Karison Foods & Snacks Inc Recalls ‘PANJIRI’, ‘ALSI PINNI’, ‘PUNJABI PINNI’, ‘BESAN LADDOO’, and ‘NO SUGAR ADDED BESAN LADDOO’ Due to Undeclared Milk Allergen

Karison Foods & Snacks Inc of Port Washington, NY 11050 is recalling 12 oz containers of ‘PANJIRI’, ‘ALSI PINNI’, ‘PUNJABI PINNI’, ‘BESAN LADDOO’, and ‘NO SUGAR ADDED BESAN LADDOO’ due to undeclared milk allergen

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FDA Press Releases
3 weeks ago

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective t

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FDA Press Releases
3 weeks ago

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).

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FDA Recalls
3 weeks ago

Diva Fam Inc. Announces Voluntary Recall Of Sea Moss Gel Superfood Products Due to Possible Health Risk

LOS ANGELES, Jan. 9, 2026 - Diva Fam Inc. ("Diva Fam" or the "Company") today (January 9, 2026) announced a voluntary recall of all lots and flavors of Sea Moss Gel Superfood due to lack of required regulatory authorization and temperature monitoring records for pH-controlled food products

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FDA Recalls
3 weeks ago

HerbsForever LLC Issues Allergy Alert on Undeclared Wheat in HerbsForever brand Dietary Supplements

01/07/2026 - HerbsForever LLC of Los Angeles, California is recalling 45 units of the product “Hingwastik Churna” and 45 units of “Gastro Care” dietary supplements because they may contain undeclared wheat. People who have a wheat allergy run a risk of serious or life-threatening allergic reactions

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MedWatch Safety Alerts
3 weeks ago

Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits

AVID is removing bags from Organ Recovery and Medical Convenience Kits due to the bags being made of non-medical grade Poly and lacking intact seals.

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MedWatch Safety Alerts
3 weeks ago

Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.

[Phoenix, Arizona] – [12/22/25] – Modern Warrior is voluntarily recalling all lots of Modern Warrior Ready, a dietary supplement sold directly to consumers, after regulatory testing identified the presence of undeclared ingredients, including tianeptine, 1,4-DMAA, and aniracetam..Tianeptine can c

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MedWatch Safety Alerts
3 weeks ago

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with meloxicam. Meloxicam, is an approved Nonsteroidal Anti-Inflammatory Drug, (NSAID) indicated for management of osteoarthritis

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FDA Recalls
4 weeks ago

Gusto Group Inc. Recalls Shrimp Paste (Klong Kone) ‘'454 G. (1 LBS)’ and ‘910 G. (2 LBS)’ because of Possible Health Risk

Gusto Group Inc. of Paterson, NJ is recalling [Klong Kone] Shrimp Paste (Klong Kone) '454 G. (1 LBS)' and ‘910 G. (2 LBS)’ because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that

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FDA Recalls
Jan 6

Carrot Top Kitchens of Bridgeport (formerly Redding) Issues a Class II Recall of Hummus Containing Undeclared Sesame

HARTFORD — The Connecticut Department of Consumer Protection Food and Standards Division is warning the public that Carrot Top Country Kitchens LLC, DBA Carrot Top Kitchens of Bridgeport (formerly Redding), is recalling 5 varieties of hummus due to undeclared sesame.

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MedWatch Safety Alerts
Jan 5

Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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MedWatch Safety Alerts
Jan 5

Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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MedWatch Safety Alerts
Jan 5

Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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FDA Recalls
Jan 5

Primavera Nueva Inc. Issues Voluntary Recall of Select 4-Count Tamales Because of Possible Health Risk- Revised to Include Roasted Pumpkin & White Cheddar, a Seasonal Item

Sonoma, CA — Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes, an organism which

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MedWatch Safety Alerts
Jan 5

Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

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MedWatch Safety Alerts
Jan 5

Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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MedWatch Safety Alerts
Jan 5

Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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MedWatch Safety Alerts
Jan 2

Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs

Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.

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MedWatch Safety Alerts
Dec 30, 2025

Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set

ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.

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MedWatch Safety Alerts
Dec 30, 2025

Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

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FDA Press Releases
Dec 29, 2025

FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products

The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

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MedWatch Safety Alerts
Dec 29, 2025

Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software

A defect was discovered in the Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 that may cause the app to shut down unexpectedly.

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