[ WEEKLY GxP BRIEFING · ARCHIVE ]

Every briefing item, in one running record.

The full archive behind the Weekly GxP Briefing — FDA rules and notices, recalls, guidance, and regulatory milestones across every industry SPEQ covers. Each item links to its primary source.

Live — auto-refreshed126 items · composed from the scheduled ingests

60 Recalls14 Rules46 Notices6 Milestones

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This is the running feed across every source SPEQ tracks, so Source is the first cut — a rule from the Federal Register and a recall from openFDA answer different questions. Then narrow by type or priority. Rows open the publishing body’s own page.

Items are regulator records reproduced as published; SPEQ adds no interpretation. Priority is SPEQ’s triage of how urgently a practitioner should look, not a regulator’s classification, and it is not a safety rating.

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2026-09-11Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device TrackingThe Food and Drug Administration (FDA, Agency, or we) 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 to publish no…Health and Human Services DepartmentNotice

2026-09-11Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine SalicylateThe Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human U…Health and Human Services DepartmentNotice

2026-09-11Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and FeedThe Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.Health and Human Services DepartmentNotice

2026-09-11Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification SoftwareThe Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software 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 cod…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT SurgeryThe Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing SystemThe Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system 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 codified language for classific…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence DeviceThe Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device 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 codified…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel DiseaseThe Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in th…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation ProceduresThe Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this or…Health and Human Services DepartmentRuleHIGH

2026-09-10Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular AccessThe Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part…Health and Human Services DepartmentRuleHIGH

2026-09-10Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as…Health and Human Services DepartmentRule

2026-09-10Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation ProceduresThe Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this orde…Health and Human Services DepartmentRuleHIGH

2026-09-10Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority re…Health and Human Services DepartmentNotice

2026-09-10Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction DeviceThe Food and Drug Administration (FDA) is classifying the whole room microbial reduction device 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 codified language for cla…Health and Human Services DepartmentRuleHIGH

2026-09-09Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus VaccinesThe Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations…Health and Human Services DepartmentNotice

2026-09-09Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVAThe Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to…Health and Human Services DepartmentNotice

2026-09-09Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regu…Health and Human Services DepartmentNotice

2026-09-09Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRYThe Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to…Health and Human Services DepartmentNotice

2026-09-09Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health CommunicationsThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-09-09Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based ProductsThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-09-09Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGOThe Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to…Health and Human Services DepartmentNotice

2026-09-04Advancing Development of Botanical Drug Products; Request for InformationThe Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders' perspe…Health and Human Services DepartmentNotice

2026-09-03Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessThe Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsule…Health and Human Services DepartmentNotice

2026-09-02Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in t…Health and Human Services DepartmentNotice

2026-09-02Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessThe Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not beg…Health and Human Services DepartmentNotice

2026-09-02International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).…Health and Human Services DepartmentNotice

2026-09-02Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr)The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers…Health and Human Services DepartmentNotice

2026-09-02Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions.…Health and Human Services DepartmentNotice

2026-09-02International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)…Health and Human Services DepartmentNotice

2026-09-02Botticelli Foods, LLC — bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961Product may be contaminated with Salmonella.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02American Contract Systems Inc — American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.U.S. Food and Drug AdministrationRecall

2026-09-02CUISINE, KETTLE — Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Che…Product had a presumptive positive test result for Listeria monocytogenesU.S. Food and Drug AdministrationRecall

2026-09-02UPSTATE NIAGARA COOPERATIVE — Mehadrin Chocolate Leben; 6 OZ (170g) CUPS, UPC: 070784023144Product may have been improperly pasteurized.U.S. Food and Drug AdministrationRecall

2026-09-02AVID Medical, Inc. — Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.U.S. Food and Drug AdministrationRecall

2026-09-02H & U Inc. dba Sun Noodle — Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net…Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02ZMB Enterprises — Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplementThe product contains 1,4-DMAA, Phenylethylamine and Phenibut.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02Dreyer's Grand Ice Cream Inc. — Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in p…Foreign object: products may contain glass piecesU.S. Food and Drug AdministrationRecall

2026-09-02Byron White Formulas, Inc. — Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (J…Label does not declare walnuts in EnglishU.S. Food and Drug AdministrationRecall

2026-09-02IMRIS Imaging Inc — ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned,…The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occ…U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02American Contract Systems Inc — American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.U.S. Food and Drug AdministrationRecall

2026-09-02Apotex Corp. — Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufac…Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteriaU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manuf…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Philips Healthcare (Suzhou) Co., Ltd. — Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Potential of failing to trigger clinical scan during Bolus Tracking.U.S. Food and Drug AdministrationRecall

2026-09-02Dreyer's Grand Ice Cream Inc. — Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in pap…Foreign object: products may contain glass piecesU.S. Food and Drug AdministrationRecall

2026-09-02Lidl US TRADING — ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coco…The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).U.S. Food and Drug AdministrationRecall

2026-09-02Lidl US TRADING — ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling…The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).U.S. Food and Drug AdministrationRecall

2026-09-02KHONG GUAN (HQ) — BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Pr…Undeclared peanuts.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02FUJIFILM Healthcare Americas Corporation — FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemSoftware issue may cause the ruler measurement to be inaccurate.U.S. Food and Drug AdministrationRecall

2026-09-02ConMed Corporation — CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5…Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q;…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02Midmark Corporation — Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version…A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.U.S. Food and Drug AdministrationRecall

2026-09-02Henry Schein Inc. — Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr P…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB,…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may p…U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABD…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02Henry Schein Inc. — Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.U.S. Food and Drug AdministrationRecall

2026-09-02American Contract Systems Inc — American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.U.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufa…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Healthmark Industries Co., Inc. — healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Tes…Test manufactured with an expired ingredient which may present as either a false negative or positive.U.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufa…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJ…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ942599…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02GE Medical Systems Information Technologies Inc — PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or c…U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, M…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may p…U.S. Food and Drug AdministrationRecall

2026-09-02Africando Foods LLC — Clear glass bottle with black screw lid with multi label which reads in part as "***AFRIC…Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient listU.S. Food and Drug AdministrationRecall

2026-09-02American Contract Systems Inc — American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HThe Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.U.S. Food and Drug AdministrationRecall

2026-09-02Lupin Pharmaceuticals Inc. — Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharm…Failed content uniformity specifications.U.S. Food and Drug AdministrationRecall

2026-09-02AVID Medical, Inc. — Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W…Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.U.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufac…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Olympus Corporation of the Americas — POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.…Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.U.S. Food and Drug AdministrationRecall

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Mallinckrodt Hospital Products Inc. — Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. f…Presence of particulate matter: glass and stopper pieceU.S. Food and Drug AdministrationRecall

2026-09-02Hikma Pharmaceuticals USA INC. — Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 C…Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).U.S. Food and Drug AdministrationRecall

2026-09-02Church & Dwight Co., Inc. — Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-U…CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testingU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (N…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufa…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactu…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02B BRAUN MEDICAL INC — Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medica…Presence of Particulate matter.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C;…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manuf…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (N…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufa…Subpotent DrugU.S. Food and Drug AdministrationRecall

2026-09-02Fresenius Kabi USA, LLC — Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufa…Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.U.S. Food and Drug AdministrationRecallHIGH

2026-09-02Medline Industries, LP — Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturerU.S. Food and Drug AdministrationRecall

2026-09-01Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessThe Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not b…Health and Human Services DepartmentNotice

2026-08-31Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting FormThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.Health and Human Services DepartmentNotice

2026-08-31Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; AvailabilityThe Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an anima…Health and Human Services DepartmentNotice

2026-08-31Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated FeesThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-31Rahim Shafa; Denial of Hearing; Final Debarment OrderThe Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services…Health and Human Services DepartmentNotice

2026-08-31Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and CorrectionsThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-28Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed ContainersThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-28Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This dr…Health and Human Services DepartmentNotice

2026-08-28Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug AdministrationThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-28Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service DeliveryThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-28Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User FeesThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.Health and Human Services DepartmentNotice

2026-08-28Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription DrugsThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.Health and Human Services DepartmentNotice

2026-08-27Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second 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, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Produ…Health and Human Services DepartmentNotice

2026-08-26Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological HealthThe 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 to publish notice…Health and Human Services DepartmentNotice

2026-08-26International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for CommentsThe Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical us…Health and Human Services DepartmentNotice

2026-08-26Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessThe Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination…Health and Human Services DepartmentNotice

2026-08-24Evaluation of Therapeutic Equivalence; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equiv…Health and Human Services DepartmentNotice

2026-08-24Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence…Health and Human Services DepartmentNotice

2026-08-24Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitle…Health and Human Services DepartmentNotice

2026-08-21Advisory Committee; Oncologic Drugs Advisory Committee; RenewalThe Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs…Health and Human Services DepartmentNotice

2026-08-20Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a…Health and Human Services DepartmentNotice

2026-08-20Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; RenewalThe Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew…Health and Human Services DepartmentNotice

2026-08-20Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; RenewalThe Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the…Health and Human Services DepartmentNotice

2026-08-20Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequentl…Health and Human Services DepartmentNotice

2026-08-19GNT USA, LLC.; Filing of Color Additive PetitionThe Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.)…Health and Human Services DepartmentRule

2026-08-19Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine ChelateThe Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in catt…Health and Human Services DepartmentRuleHIGH

2026-08-19International Association of Color Manufacturers; Filing of Color Additive PetitionThe Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the International Association of Color Manufacturers, proposing that we amend our color additive regulations to provide for the safe use of acetone as a sol…Health and Human Services DepartmentRule

2026-08-19Gardenia Blue Interest Group; Filing of Color Additive PetitionThe Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gard…Health and Human Services DepartmentRule

2026-08-18Testosterone Use in Menopausal Women; Public Workshop; Request for CommentsThe Food and Drug Administration's (FDA) Office of Women's Health and the Center for Drug Evaluation and Research are announcing a public workshop titled "Testosterone Use in Menopausal Women." The purpose of the public workshop is to examine the current scie…Health and Human Services DepartmentNotice

2026-08-18Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to…Health and Human Services DepartmentNotice

2026-08-17Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application RequirementsThe Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.Health and Human Services DepartmentNotice

2024-08-25Annex 1 section 8.123 deferred provision in forceThe deferred Annex 1 provision relating to lyophilizer transfer and loading became operative one year after the main text.EMA / European CommissionMilestone

2023-11-01ICH Q2(R2) and Q14 on analytical procedures reached Step 4Q14 and revised Q2(R2) formalized lifecycle and QbD concepts for analytical procedure development and validation.ICHMilestone

2023-08-25EU GMP Annex 1 (2022) came into operationThe revised Annex 1 introduced the mandatory Contamination Control Strategy (CCS) across the EU and PIC/S member states.EMA / European CommissionMilestoneHIGH

2023-01-18ICH Q9(R1) Quality Risk Management reached Step 4The revised Q9 guideline added guidance on formality, subjectivity and bias, and risk review for regulated quality decisions.ICHMilestone

2022-11-01PSCP Advisory Committee recommends FDA establish a QMM programIn November 2022 the Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously to recommend CDER establish a Quality Management Maturity rating program to help reduce drug shortages and recalls.FDAMilestone

2022-07-01ISPE GAMP 5 Second Edition publishedThe GAMP 5 second edition updated computerized system validation guidance for cloud computing, agile delivery, and modern software.ISPEMilestone

Every count on this page is composed at request time from the live-intelligence tables and the curated milestones — none is a literal. Follow each link for the publishing body’s authoritative record.

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Live sources: Federal Register · FDA