This Week at FDA
In the 14 days to Nov 12, 2026, FDA announced 9 recalls and 11 safety alerts, issued 4 press releases and published 13 rules and proposed rules and 9 notices in the Federal Register.
- Recalls: 9
- Safety alerts: 11
- Rules and proposed rules: 13
- Notices: 9
By Kind
Oct 30, 2026 to Nov 12, 2026, updated hourly.
- Recall920%
- Safety alert1124%
- Press release49%
- Rule1124%
- Proposed rule24%
- Notice920%
46 announcements, newest first
| Announcement | Kind | Date |
|---|---|---|
| Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for InformationThe Food and Drug Administration (FDA or Agency), is announcing a request for information (RFI) from interested parties to share perspectives on patient-level data access related to the use of real-world evidence (RWE) in regulatory decisio | Notice | Nov 12, 2026 |
| Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Early-Phase IND Protocol Recommendations for Solid Tumors." The purpose of this draft guidance is to provide recommenda | Notice | Nov 12, 2026 |
| Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer ProgramThe Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required | Notice | Nov 12, 2026 |
| Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed DirectiveThe Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required | Notice | Nov 12, 2026 |
| Hematology and Pathology Devices; Reclassification of Immunohistochemistry Test Systems for Use With a Corresponding Approved Oncology Therapeutic ProductThe Food and Drug Administration (FDA) is proposing to reclassify immunohistochemistry (IHC) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes MVC, NKF, QQT, NQF, PLS, PKW, QUL, QNH, QZ | Proposed rule | Nov 12, 2026 |
| Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and AcetaminophenNovember 12, 2026 - Tampa, Florida. Game Changer Products LLC is voluntarily recalling all lots of 10 Day Forecast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and acetaminophen. Sildenafi | Recall | Nov 12, 2026 |
| Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared TadalafilEros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey because the product was found to contain undeclared tadalafil. | Recall | Nov 12, 2026 |
| Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The guidance desc | Notice | Nov 10, 2026 |
| Laub's Feeding & Cubing, Inc. Voluntary Recalls Grade A Mini Hay Cubes Because of Potential Clostridium Botulinum ContaminationLaub’s Feeding and Cubing, Inc. of Beryl, Utah is voluntary recalling up 89 ton of Grade A Mini Hay Cubes sold from October 3 – October 31 because the product has the potential to be contaminated with Clostridium botulinum, a bacterium that | Recall | Nov 10, 2026 |
| Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health RiskWorcester, New York – Family Farmstead Dairy is recalling all cheddar cheese products because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young c | Recall | Nov 10, 2026 |
| Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene DichlorideThe Food and Drug Administration (FDA or we) is partially granting a color additive petition submitted by the International Association of Color Manufacturers (IACM or petitioner), by amending our color additive regulations, on the basis of | Rule | Nov 10, 2026 |
| Color Additive Petition From Environmental Defense Fund et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and TrichloroethyleneThe Food and Drug Administration (FDA or we) is partially granting a color additive petition submitted by Environmental Defense Fund et al. (petitioners), by amending our color additive regulations, on the basis of the Delaney Clause, to re | Rule | Nov 10, 2026 |
| Early Alert: Arrow International Removes Products Containing Spring Wire Guide ComponentsSpring Wire Guides containing hydrophilic coating may detach and release particles into the bloodstream, risking embolism. | Safety alert | Nov 10, 2026 |
| Early Alert: Intersurgical Inc. Removes 22mm Smoothbore breathing tubes and systemsIntersurgical removes 22mm Smoothbore breathing tubes and systems because connectors may detach, causing ventilation loss, brain damage, or death. | Safety alert | Nov 10, 2026 |
| FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High RiskFDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic isch | Press release | Nov 9, 2026 |
| MedWatch Alert: FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety CommunicationFDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication | Safety alert | Nov 9, 2026 |
| Convenience Kit Correction: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion SetsCardinal Health Presource Kits may contain BD Alaris Pump Infusion Sets with Updated Use Instructions. | Safety alert | Nov 9, 2026 |
| Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC)Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records. | Safety alert | Nov 9, 2026 |
| Fresh & Ready Foods LLC Recalls Fresh To You Brand Sausage, Egg & Cheese Biscuit Sandwich due to Possible Health RiskNovember 7, 2026, Fresh & Ready Foods LLC of Renton, WA is recalling 2,414 of Fresh To You Sausage, Egg & Cheese Biscuit Sandwiches (4.6 oz) because it has the potential to be contaminated with Listeria monocytogenes, an organism wh | Recall | Nov 8, 2026 |
| Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate MatterNovember 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) to the hospital/healthca | Recall | Nov 6, 2026 |
| Food Additive Petitions; Change of AddressThe Food and Drug Administration (FDA or the Agency) is amending the regulations for food additive petitions (FAPs) to update addresses and simplify notification procedures. These technical amendments are being made to improve the accuracy | Rule | Nov 6, 2026 |
| Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of CongestionThe Food and Drug Administration (FDA) is classifying the external mechanical stimulator for the relief of congestion into class II (special controls). The special controls that apply to the device type are identified in this order and will | Rule | Nov 6, 2026 |
| MedWatch Alert: FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene TherapyFDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy: FDA Safety Communication | Safety alert | Nov 6, 2026 |
| FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell CarcinomaThe U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose d | Press release | Nov 5, 2026 |
| Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence AlgorithmThe Food and Drug Administration (FDA) is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). The special controls that apply to the device type are identif | Rule | Nov 5, 2026 |
| Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive ImpairmentThe Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls). The special controls that apply to the device type are identified in this order and will | Rule | Nov 5, 2026 |
| Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic UseThe Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the | Rule | Nov 5, 2026 |
| Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potency | Notice | Nov 3, 2026 |
| Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document provides blood establishm | Notice | Nov 3, 2026 |
| Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask ResuscitatorsCompact Medical removes and updates use instructions for certain ButterflyBVM devices due to development of holes in bellows.<br> <br> | Safety alert | Nov 3, 2026 |
| FDA Provides Clarity to Support Cell and Gene Therapy Development and QualityThe U.S. Food and Drug Administration today issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards | Press release | Nov 2, 2026 |
| Infant Formula Nutrient RequirementsThe Food and Drug Administration (FDA or we) proposes to amend the regulations on nutrient specifications and labeling for infant formula as part of its phased, comprehensive review of infant formula nutrients. This action, if finalized, wo | Proposed rule | Nov 2, 2026 |
| Snack Right Super Foods, Inc. dba Brad's Raw Chips Recalls Brad's Crunchy Kale & Veggie Chips Due to Potential Thallium ContaminationCoral Gables, FL - Snack Right Super Foods, Inc., doing business as Brad's Raw Chips, is recalling certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may contain thallium. | Recall | Nov 2, 2026 |
| MedWatch Alert: FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked BarsConsumers Should Not Buy or Serve Once Upon a Farm Tractor Wheels, Organic Toddler Soft-Baked Bars Due to a Potentially Fatal Choking Hazard | Safety alert | Nov 2, 2026 |
| Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss. | Safety alert | Nov 2, 2026 |
| Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Prod | Notice | Oct 30, 2026 |
| Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combin | Notice | Oct 30, 2026 |
| FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory PapillomatosisThe U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP). | Press release | Oct 30, 2026 |
| Once Upon A Farm Recalls All Lots and Varieties of Tractor Wheels Organic Toddler Soft-Baked Bars Due to Potential Choking HazardOnce Upon a Farm (Berkeley, CA) is recalling all lots and varieties of fruit-flavored Tractor Wheel Organic Toddler Soft-Baked bars due to reports that the composition of the Tractor Wheel toddler snack can rapidly hydrate into a dense, dry | Recall | Oct 30, 2026 |
| Vitality Works Inc. Recalls 365 Whole Foods Market Ashwagandha Capsules Sold Nationwide Due to Potential Salmonella ContaminationVitality Works Inc. of Albuquerque, New Mexico, is recalling one lot (lot number 2025-26227) of 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha Capsules 120 count because it has the potential to be contaminated with Sa | Recall | Oct 30, 2026 |
| Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep ApneaThe Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be pa | Rule | Oct 30, 2026 |
| Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial ProceduresThe Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of t | Rule | Oct 30, 2026 |
| Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung DiseaseThe Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II (special controls). The special controls that apply to the device type are identified in th | Rule | Oct 30, 2026 |
| Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin CancerThe Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls that apply to the devic | Rule | Oct 30, 2026 |
| Hospital Glucose Meter Correction: Nova Biomedical Updates Use Instructions for StatStrip Glucose Hospital Meter SystemsUpdate use instructions for StatStrip Glucose Hospital Meter Systems due to the potential for glucose results to be assigned to the incorrect patient. | Safety alert | Oct 30, 2026 |
| Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)Product performance issue may lead to a false negative result which will delay recognition of heparin-induced thrombocytopenia. | Safety alert | Oct 30, 2026 |
Recall announcements, MedWatch safety alerts and press releases from FDA's RSS feeds (each lists FDA's latest 20), and FDA documents from the Federal Register API. Recall announcements are the ones firms and FDA publicize; FDA's full enforcement report adds more, with a one to two week lag. FDA RSS feeds and the Federal Register