On March 12, 2024, Eli Lilly & Company initiated a recall involving HUMALOG U-100 (insulin lispro injection), NDC 0002-0800-01. The recall also covers Sterile Diluent and HUMULIN R U-100 Regular (insulin human injection) products marketed under the same line.
The FDA classified this action as a Class II recall. The stated reason for the recall is CGMP deviations, referring to current Good Manufacturing Practice concerns identified for these products.
According to FDA records, the recall status is listed as Completed. The affected product was marketed by Lilly USA, LLC, based in Indianapolis, Indiana, and is intended for use only with insulins listed on the product carton.
This recall record is identified by FDA number D-0445-2024. The classification and reason reflect regulatory categorization of manufacturing process deviations rather than a determination of harm caused by the product itself.
For readers seeking more background on this compound, see the insulin lispro overview for additional context.