Quick answers
- What is Semaglutide used for?
- The FDA-approved label (Ozempic, A-S Medication Solutions, July 30, 2026) says: “OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Semaglutide have a boxed warning?
- Yes. The FDA label for Ozempic has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Semaglutide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 4, 2026). Ask your pharmacist about alternatives.
- Has Semaglutide been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 19, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Semaglutide?
- 2 companies list prescription products of Semaglutide in the FDA NDC Directory, including Novo Nordisk Pharmaceutical Industries, LP and A-S Medication Solutions.
What Semaglutide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. …
— FDA label: Ozempic, A-S Medication Solutions, effective July 30, 2026. Read the full label on DailyMed →
The FDA has 5 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.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| semaglutide 0.25 mg/0.5 mL injection, solution | Brand: Wegovy | $653.33 per mL |
| semaglutide 0.5 mg/0.5 mL injection, solution | Brand: Wegovy | $653.30 per mL |
| semaglutide 0.68 mg/mL injection, solution | Brand: Ozempic | $332.02 per mL |
| semaglutide 1 mg/0.5 mL injection, solution | Brand: Wegovy | $653.07 per mL |
| semaglutide 1.34 mg/mL injection, solution | Brand: Ozempic | $331.94 per mL |
| semaglutide 1.5 mg tablet | Brand: Ozempic | $33.15 per tablet |
| semaglutide 1.5 mg tablet | Brand: Wegovy | $43.53 per tablet |
| semaglutide 1.7 mg/0.75 mL injection, solution | Brand: Wegovy | $435.57 per mL |
| semaglutide 14 mg tablet | Brand: Rybelsus | $33.19 per tablet |
| semaglutide 2.4 mg/0.75 mL injection, solution | Brand: Wegovy | $435.57 per mL |
| semaglutide 2.68 mg/mL injection, solution | Brand: Ozempic | $332.00 per mL |
| semaglutide 25 mg tablet | Brand: Wegovy | $43.46 per tablet |
| semaglutide 3 mg tablet | Brand: Rybelsus | $33.19 per tablet |
| semaglutide 4 mg tablet | Brand: Ozempic | $33.19 per tablet |
| semaglutide 4 mg tablet | Brand: Wegovy | $43.49 per tablet |
| semaglutide 7 mg tablet | Brand: Rybelsus | $33.19 per tablet |
| semaglutide 7.2 mg/0.75 mL injection, solution | Brand: Wegovy | $434.94 per mL |
| semaglutide 9 mg tablet | Brand: Ozempic | $33.19 per tablet |
| semaglutide 9 mg tablet | Brand: Wegovy | $43.48 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Novo Nordisk Pharmaceutical Industries, LP20 products
- A-S Medication Solutions4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209637 OZEMPIC | Novo | December 5, 2017 | 15, latest August 27, 2026 2026: Labeling · 2026: Labeling · 2026: Manufacturing (CMC) |
| NDA213051 OZEMPIC, RYBELSUS | Novo | September 20, 2019 | 12, latest January 30, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
| NDA215256 WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | Novo | June 4, 2021 | 15, latest June 18, 2026 2026: Manufacturing (CMC) · 2026: Manufacturing (CMC) · 2026: Efficacy |
| NDA218316 WEGOVY | Novo | December 22, 2025 | 5, latest June 18, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
Shortage status
To be discontinued · updated June 4, 2026 · first posted June 4, 2026
| Product | Rybelsus, Tablet, 3 mg (NDC 0169-4303-30) |
|---|---|
| Company | Novo Nordisk, Inc. |
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.
-
December 19, 2025 · Class II · Ongoing · D-0245-2026
Presence of Particulate Matter: Hair was found in a prefilled syringe
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC — Novo Nordisk Inc.
-
December 19, 2025 · Class II · Ongoing · D-0244-2026
Presence of Particulate Matter: Hair was found in a prefilled syringe
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, N — Novo Nordisk Inc.
-
April 9, 2025 · Class II · Ongoing · D-0393-2025
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately releas
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, D — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0536-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd — Cardinal Health Inc.
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ozempic, A-S Medication Solutions, effective July 30, 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 →