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.
2 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: HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved un…
Approved for: REZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly know…
Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.
14 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.
Reason: Failed Dissolution Specifications.
Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Reason: Failed Impurity/Degradation Specifications
Reason: Failed Impurity/Degradation Specifications
Reason: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as ataza…
Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.
31 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: The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient,…
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Reason: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however…
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however…
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly…
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly…
Reason: Distribution without premarket approval/clearance.
Reason: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase th…
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
10 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Company: Traferox Technologies, Inc.
Company: Perspectum, Ltd.
Company: Eieling Technology (Shenzhen) Limited
Company: Truvian Health
Company: Boehringer Laboratories, LLC
Company: Vinbrain Joint Stock Company
Company: Eieling Technology (Shenzhen) Limited
Company: Argon Medical Devices, Inc.
Company: Eieling Technology Limited
Company: MeVis Medical Solutions AG
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
14,287 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.
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