Updates ·
Health notices · Tuesday 29 September
3 notices from the agencies today, in plain words, each with the original linked.
FDA Class II notice for Dopamine HCl injection sterility assurance
FDA · Recall
If you are prescribed Dopamine HCl Injection (dopamine), the US Food and Drug Administration has issued a Class II notice because there is a lack of assurance of sterility.
Sterility means the medicine is free from germs. If sterility isn’t assured, it may increase the risk of infection when the injection is used.
This notice applies to the product distributed nationwide, including the specific listed Dopamine HCl injection presentation.
No patient action steps were included in the notice text provided.
FDA approved finerenone (Kerendia) for certain kidney and heart risk
FDA · Approval
If you have chronic kidney disease related to type 2 diabetes, the FDA has approved Kerendia (finerenone) to help reduce the risk of sustained kidney function decline, kidney failure, cardiovascular death, certain heart attacks, and hospitalization for heart failure.
If you have heart failure with left ventricular ejection fraction (LVEF) 40% or higher, Kerendia has also been approved to reduce the risk of cardiovascular death and hospitalization for heart failure, as well as urgent heart failure visits.
Talk with your clinician about whether Kerendia is an option for your condition; this approval may expand treatment options for eligible adults starting now.
FDA Class II recall of certain chlorthalidone tablets
FDA · Recall
If you take chlorthalidone tablets made by Inventia Healthcare Limited, this FDA notice may affect you.
The FDA reports the recalled 25 mg tablets failed dissolution specifications, meaning the tablets did not meet required quality testing.
The recall involves the product identified by NDC 64980-599-01 and was published on 2026-09-23, with distribution across the U.S.