Recall Register

Food, drugs, devices › Firms

Eli Lilly & Company

FDA recalling firm · 4 enforcement events · 4 product records · 2021–2024 · IN

Eli Lilly & Company has 4 FDA enforcement events on this register (4 product records) between 2021 and 2024: 4 drug; the busiest year was 2021 with 3.

25% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in IN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
12 Mar 2024Sterile 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, Indianapolis, IN 46285. NDC: 0002-0800-01DrugClass II1Completed
24 Sep 2021Glucagon 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: 0002-8031-01DrugClass I1Terminated
19 Aug 2021Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80DrugClass II1Terminated
29 Jun 2021Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01DrugClass II1Terminated

By type and class

Drug4
Class II3
Class I1

Class I: 25% of this firm's events; 18% of all events on the register.

Events by year

21
22
23
24
25
26
Enforcement events for Eli Lilly & Company by year initiated.

Questions and answers

How many FDA recalls has Eli Lilly & Company had?

4 enforcement events (4 product records) on this register, 2021–2024: 4 drug.

Are any Eli Lilly & Company recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Eli Lilly & Company recalls?

3 Class II, 1 Class I. 25% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.