What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.
Each number has its full source under its own list below.
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.
Approved for: ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinar…
Approved for: VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO…
Approved for: FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) slowing kidney function decline in adul…
Approved for: LIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hem…
Approved for: RIVFLOZA is indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney funct…
Approved for: JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESD…
Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.
24 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.
Reason: Failed dissolution specifications
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.
142 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Reason: this is a downstream recall of class I recall RES 98777
Reason: this is a downstream recall of class I recall RES 98777
Reason: Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identi…
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Reason: Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
8 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Company: Aramis Global AI Consultancies, LLC
Company: Truvian Health
Company: Vantive US Healthcare, LLC
Company: Paragonix Technologies
Company: Healthy.Io, Ltd.
Company: Renalytix Ai, Inc.
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
62,928 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.
Countries side by side on public measures for this topic.
Worldwide · 2024–2034
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View report Medical DevicesWorldwide · 2024–2034
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