Food, drugs, devices › Eli Lilly & Company
Drug recall: Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. R
Eli Lilly & Company (Indianapolis, IN) initiated this drug recall on 24 Sep 2021; FDA lists 1 product record under event 88764, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 19% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 6 Sep 2024. Initiation: voluntary: firm initiated. Eli Lilly & Company has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Eli Lilly & Company, Indianapolis, IN.
Reason for recall
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 19,174 syringes | Class I | Terminated | 20 Oct 2021 |
Context
Other enforcement events for Eli Lilly & Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Mar 2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Li | Drug | Class II | 1 |
| 19 Aug 2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46 | Drug | Class II | 1 |
| 29 Jun 2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indian | Drug | Class II | 1 |
All 4 events for Eli Lilly & Company
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.