Eli Lilly & Company FDA Recalls

4 recalls on file across drugs, 1 of them Class I and 0 still open. Matched by name to LLY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin LiClass IIMar 12, 2024CGMP Deviations	CGMP Deviations	Class IIDrugs	Mar 12, 2024
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. RClass ISep 24, 2021SUBPOTENT DRUG: Vial contained a liquid substance, instead o	SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a	Class IDrugs	Sep 24, 2021
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46Class IIAug 19, 2021Labeling: Label error on declared strength - autoinjector de	Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain	Class IIDrugs	Aug 19, 2021
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, IndianClass IIJun 29, 2021cGMP deviations: Atypical appearance, decrease in size and c	cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug pro	Class IIDrugs	Jun 29, 2021