RecallRadar

FDA Drug recall D-0445-2024

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-10…

On 2024-04-24 the FDA classified a Class II recall of Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-10… by Eli Lilly And, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0445-2024
ClassificationClass II
Statuscompleted
Initiated2024-03-12
Published2024-04-24
Last updated2026-09-13 11:52 UTC
CompanyEli Lilly And
DistributionUS

Product

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

Reason

CGMP Deviations

Identifiers

ndc0002-7510-01
ndc0002-7510-17
ndc0002-7533-01
ndc0002-8799-01
ndc0002-8799-59
ndc0002-7516-01
ndc0002-7516-59
ndc0002-7516-99
ndc0002-7714-01
ndc0002-7714-59
ndc0002-7714-61
ndc0002-8213-01
ndc0002-8213-05
ndc0002-0800-01
ndc0002-7712-01
ndc0002-7712-27
ndc0002-7712-61
code_infoBatch number: D608951C, exp 4/10/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.