Quick answers
- What is Insulin lispro used for?
- The FDA-approved label (Humalog, Eli Lilly and Company, June 16, 2026) says: “HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Insulin lispro have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Insulin lispro?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 1, 2026). Ask your pharmacist about alternatives.
- Has Insulin lispro been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started March 12, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Insulin lispro?
- 4 companies list prescription products of Insulin lispro in the FDA NDC Directory, including Eli Lilly and Company, A-S Medication Solutions and Sanofi-Aventis U.S. LLC.
What Insulin lispro is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
— FDA label: Humalog, Eli Lilly and Company, effective June 16, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, suspension |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 29 in the FDA NDC Directory |
| Brand names | Humalog, Humalog Kwikpen, Admelog, Lyumjev, Lyumjev Kwikpen, Humalog Mix75/25, Humalog Mix75/25 Kwikpen, Humalog Tempo Pen, Insulin Lispro Kwikpen, Humalog Mix50/50 Kwikpen, Insulin Lispro Junior Kwikpen, Humalog Junior Kwikpen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| insulin lispro 100 units/mL injection, solution | Generic | $2.40–$10.19 per mL 3 packages, lowest to highest |
| insulin lispro 100 units/mL injection, solution | Brand: Admelog | $9.39–$12.56 per mL 3 packages, lowest to highest |
| insulin lispro 100 units/mL injection, solution | Brand: Humalog | $6.36–$9.79 per mL 2 packages, lowest to highest |
| insulin lispro 100 units/mL injection, solution | Brand: Humalog Junior KwikPen | $10.16 per mL |
| insulin lispro 100 units/mL injection, solution | Brand: Humalog KwikPen | $10.16 per mL |
| insulin lispro 100 units/mL injection, solution | Brand: Humalog Tempo Pen | $10.13 per mL |
| insulin lispro 100 units/mL injection, solution | Brand: LYUMJEV KwikPen | $10.15 per mL |
| insulin lispro 100 units/mL injection, solution | Brand: LYUMJEV Tempo Pen | $10.14 per mL |
| insulin lispro 100 units/mL injection, solution | Brand: Lyumjev | $7.87 per mL |
| insulin lispro 100 units/mL injection, suspension | Generic | $10.20 per mL |
| insulin lispro 100 units/mL injection, suspension | Brand: Humalog Mix50/50 KwikPen | $10.15 per mL |
| insulin lispro 100 units/mL injection, suspension | Brand: Humalog Mix75/25 | $8.15 per mL |
| insulin lispro 100 units/mL injection, suspension | Brand: Humalog Mix75/25 KwikPen | $10.16 per mL |
| insulin lispro 200 units/mL injection, solution | Brand: Humalog KwikPen | $20.31 per mL |
| insulin lispro 200 units/mL injection, solution | Brand: LYUMJEV KwikPen | $20.28 per mL |
NADAC list of November 4, 2026; these prices took effect between February 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Eli Lilly and Company19 products
- A-S Medication Solutions6 products
- Sanofi-Aventis U.S. LLC3 products
- Remedyrepack Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA020563 HUMALOG, HUMALOG KWIKPEN, HUMALOG PEN, HUMALOG TEMPO PEN | Lilly | June 14, 1996 | 84, latest May 7, 2025 2025: Labeling · 2023: Labeling · 2019: Labeling |
| BLA021017 HUMALOG MIX 75/25, HUMALOG MIX 75/25 KWIKPEN, HUMALOG MIX 75/25 PEN | Lilly | December 22, 1999 | 37, latest July 21, 2023 2023: Labeling · 2019: Labeling · 2019: Labeling |
| BLA021018 HUMALOG MIX 50/50, HUMALOG MIX 50/50 KWIKPEN, HUMALOG MIX 50/50 PEN | Lilly | December 22, 1999 | 30, latest July 21, 2023 2023: Labeling · 2019: Labeling · 2019: Labeling |
| BLA205747 HUMALOG KWIKPEN | Eli Lilly and Co | May 26, 2015 | 11, latest May 7, 2025 2025: Labeling · 2023: Labeling · 2019: Labeling |
| BLA209196 ADMELOG, ADMELOG SOLOSTAR | Sanofi-Aventis Us | December 11, 2017 | 5, latest August 31, 2023 2023: Labeling · 2019: Labeling · 2019: Labeling |
| BLA761109 LYUMJEV | Eli Lilly and Co | June 15, 2020 | 2, latest October 14, 2022 2022: Efficacy · 2021: Efficacy |
Shortage status
To be discontinued · updated September 1, 2026 · first posted September 1, 2026
| Product | Insulin Lispro Junior KwikPen, Injection, 100 [iU]/1 mL (NDC 0002-7752-05) |
|---|---|
| Company | Eli Lilly and Co. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 12, 2024 · Class II · Completed · D-0445-2024
CGMP Deviations
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 — Eli Lilly & Company
-
April 11, 2023 · Class II · Ongoing · D-0575-2023
Lack of Assurance of Sterility: Malformed crimped collar seal
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05 — Sanofi-Aventis U.S. LLC
-
April 5, 2022 · Class I · Completed · D-0882-2022
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59 — Cardinal Health Inc.
-
July 5, 2018 · Class II · Ongoing · D-0925-2018
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0 — Sanofi-Aventis U.S. LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 242120, 259111, 752388, 847211, 847213, 847252, 847254, 865098, 1652239, 1652242 … (+10) |
|---|---|
| SPL set ID of the quoted label | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f |
| FDA labels (SPL) | 12 |
| FDA applications | BLA020563, BLA021017, BLA021018, BLA205747, BLA209196, BLA761109 |
| Active ingredients (FDA) | INSULIN LISPRO |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Humalog, Eli Lilly and Company, effective June 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →