Eli Lilly & Co

FDA Regulatory Profile

Eli Lilly & Co appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 7 510(k) clearances, 36 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0445-2024, Class II) was initiated on Mar 12, 2024. Its most recent 510(k) clearance was granted on Sep 16, 2022.

Summary

Total Recalls
5 (1 Class I)
510(k) Clearances
7
Inspections
36
Compliance Actions
3

Known Names

Eli Lilly And, Eli Lilly And Company, Eli Lilly And Company India Pvt

Recent Recalls

NumberClassProductDate
D-0445-2024Class IISterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human inMar 12, 2024
D-0009-2022Class IGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for GlucaSep 24, 2021
D-0773-2021Class IITrulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company,Aug 19, 2021
D-0720-2021Class IIZyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: LiJun 29, 2021
D-0248-2019Class IIIERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, ManufactuNov 8, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K212217Tempo Smart ButtonSep 16, 2022
K160949Go Dose SystemDec 22, 2016
K142518HumaPen LuxuraJun 5, 2015
K100988HUMAPEN LUXURA HDAug 17, 2010
K063151HUMAPEN LUXURA HDJan 9, 2007
K053563HUMAPEN MEMOIRApr 7, 2006
K982842HUMAPEN AND HUMAPEN ERGOSep 25, 1998