- 6new drug approvals (since 1 Jan 2023)
- 13drug recalls (since 1 Jan 2023)
- 136device recalls (since 1 Jan 2023)
- 87510(k) clearances (since 1 Jan 2023)
- 171,463side effect reports (reports received since 1 Jan 2023)
Each number has its full source under its own list below.
New drug approvals
6 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.
Garzulys (insulin aspart-fsan)
Approved for: Garzulys™ is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Garzulys is rapid acting human insulin analog indicated to improve glyc…
Lumvoa (veligrotug)
Approved for: LUMVOA is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. LUMVOA is an insulin-like growth factor-1 receptor inhibitor i…
Kirsty (water)
Approved for: KIRSTY is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. • KIRSTY is rapid acting human insulin analog indicated to improve glycemi…
Merilog (insulin aspart-szjj)
Approved for: MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. MERILOG is rapid acting human insulin analog indicated to improve glycemi…
Inpefa (sotagliflozin)
Approved for: INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes…
Brenzavvy (bexagliflozin)
Approved for: Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Bexagliflozin is not recommen…
Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.
Drug recalls
13 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled s…
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathe…
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathe…
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathe…
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Reason: Presence of Foreign Tablets/Capsules.
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Li…
Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tabl…
Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.
Device recalls
136 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Alternate Controller Enabled Insulin Infusion Pump
Reason: Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigat…
Continuous Glucose Monitor Retrospective Data Analysis Software
Reason: CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs…
Calculator, Drug Dose
Reason: A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose remin…
Alternate Controller Enabled Insulin Infusion Pump
Reason: Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 fun…
Prescription Use Blood Glucose Meter For Near-Patient Testing
Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient id…
Prescription Use Blood Glucose Meter For Near-Patient Testing
Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient id…
Prescription Use Blood Glucose Meter For Near-Patient Testing
Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient id…
Prescription Use Blood Glucose Meter For Near-Patient Testing
Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient id…
Prescription Use Blood Glucose Meter For Near-Patient Testing
Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient id…
Alternate Controller Enabled Insulin Infusion Pump
Reason: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P…
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
510(k) clearances
87 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Safe Aq Easy Blood Glucose Monitoring System; Safe Aq Care Blood Glucose Monitoring System
Company: Changsha Sinocare, Inc.
Easymax Voice Blood Glucose Monitoring System
Company: EPS Bio Technology Corp.
Vivachek Blood Glucose And ß-ketone Dual Ble Monitoring System;vivachek Blood Glucose And ß-ketone Dual Monitoring System.
Company: Vivachek Biotech (Hangzhou) Co., Ltd.
Cvs Advanced Plus Blood Glucose Monitoring System
Company: I-Sens, Inc.
Pivot Insulin Delivery System
Company: Modular Medical, Inc.
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
Company: Abbott Diabetes Care
Stelo Glucose Biosensor System
Company: Dexcom, Inc.
True Metrix Self Monitoring Blood Glucose System
Company: Trividia Health, Inc.
Ultra-fine Safety Insulin Syringe
Company: embecta Medical II, LLC
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
Side effects people report
171,463 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.
Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.
Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.
Benchmarks on diabetes
Countries side by side on public measures for this topic.
Market reports on diabetes
Anti-Obesity Drugs
Worldwide · 2024–2034
View report Medical DevicesAutomated Insulin Delivery Systems
Worldwide · 2024–2034
View report Medical DevicesBariatric Surgery Devices
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View report Public HealthCardiometabolic Risk in South Asians Public Health Report
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View report Healthcare ServicesChronic Care Management Services
Worldwide · 2024–2034
View report Digital HealthChronic Disease Management Apps
Worldwide · 2024–2034
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