Quick answers
- What is Lanreotide acetate used for?
- The FDA-approved label (Somatuline Depot, Ipsen Biopharmaceuticals, Inc., October 11, 2024) says: “SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lanreotide acetate have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lanreotide acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lanreotide acetate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started March 13, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lanreotide acetate?
- 4 companies list prescription products of Lanreotide acetate in the FDA NDC Directory, including Cipla USA Inc., Ipsen Biopharmaceuticals, Inc. and Exelan Pharmaceuticals Inc..
What Lanreotide acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. …
— FDA label: Somatuline Depot, Ipsen Biopharmaceuticals, Inc., effective October 11, 2024. Read the full label on DailyMed →
The FDA has 4 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.
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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Somatuline Depot |
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.
- Cipla USA Inc.6 products
- Ipsen Biopharmaceuticals, Inc.3 products
- Exelan Pharmaceuticals Inc.3 products
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022074 SOMATULINE DEPOT | Ipsen Pharma | August 30, 2007 | 19, latest July 11, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2019: Manufacturing (CMC) |
| NDA215395 LANREOTIDE ACETATE | Invagen Pharms | December 17, 2021 | 2, latest September 16, 2024 2024: Efficacy · 2024: Labeling |
Generic approvals (2)
- ANDA217193Invagen Pharms · May 21, 2024
- ANDA218217Amneal · September 18, 2026
Shortage status
The FDA drug shortage list does not show these products.
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 13, 2026 · Class II · Ongoing · D-0422-2026
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., — Cipla USA, Inc.
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March 13, 2026 · Class II · Ongoing · D-0423-2026
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boule — Cipla USA, Inc.
-
January 2, 2026 · Class II · Ongoing · D-0290-2026
Presence of Particulate Matter.
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Cipla USA, 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) — Somatuline Depot, Ipsen Biopharmaceuticals, Inc., effective October 11, 2024; 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 →