FDA Classifies Recall of Compounded Tirzepatide Injections as Class II Due to Sterility Concerns

The U.S. Food and Drug Administration (FDA) has classified a voluntary recall of specific lots of compounded tirzepatide injections by Apothecary Pharma LLC as Class II. This classification indicates a moderate risk of temporary or medically reversible adverse health consequences, with the risk of serious harm considered remote. The recall stems from "serious deficiencies in practices for producing drug products intended or expected to be sterile," which were identified during an FDA inspection.