Indianapolis, IN, United States
Eli Lilly & Company recalls
5 recalls recorded since 2018, most recently on 12 March 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)1
Completed Class II Drugs
- Recall started
- 12 March 2024
- Reason
- CGMP Deviations
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0445-2024
- 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, I
Terminated Class I Drugs
- Recall started
- 24 September 2021
- Terminated
- 6 September 2024
- Reason
- SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
- Distribution
- Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0009-2022
- Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Terminated Class II Drugs
- Recall started
- 19 August 2021
- Terminated
- 7 August 2023
- Reason
- Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0773-2021
- Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Terminated Class II Drugs
- Recall started
- 29 June 2021
- Terminated
- 29 July 2023
- Reason
- cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
- Distribution
- OH, MS, IN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0720-2021
- Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Terminated Class III Drugs
- Recall started
- 8 November 2018
- Terminated
- 22 April 2020
- Reason
- Labeling: Missing label; potential for missing primary container label on the vial.
- Distribution
- AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0248-2019
- ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.