Eli Lilly & Company

4 FDA enforcement actions

4 Total Recalls

1 Class I

3 Class II

0 Class III

Firm Details

Product Types: drug
States: IN

All Recalls

Class II: Risk 03/12/2024 drug

CGMP Deviations
Class I: Dangerous 09/24/2021 drug

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II: Risk 08/19/2021 drug

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.
Class II: Risk 06/29/2021 drug

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.