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Prescription medicine

Sincalide

Brand names: Kinevac

Drug class: Cholecystokinin Analog

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
4Companies
1976First FDA approval on file

Quick answers

What is Sincalide used for?
The FDA-approved label (Kinevac, Bracco Diagnostics Inc., October 18, 2023) says: “Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sincalide 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 Sincalide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sincalide been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Sincalide?
4 companies list prescription products of Sincalide in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Bracco Diagnostics Inc and Fosun Pharma USA Inc..

What Sincalide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals …

— FDA label: Kinevac, Bracco Diagnostics Inc., effective October 18, 2023. 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 formsInjection, powder, lyophilized, for solution
RouteIntravenous
Prescription products4 in the FDA NDC Directory
Brand namesKinevac

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA017697
KINEVAC		 BraccoJuly 21, 1976 21, latest October 17, 2023
2023: Labeling · 2018: Labeling · 2018: Labeling
NDA210850
SINCALIDE		 Maia Pharms IncNovember 22, 2022 1, latest October 17, 2023
2023: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. April 13, 2022 · Class II · Terminated · D-1087-2022

    cGMP deviations: Temperature abuse

    Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15 — Mckesson Medical-Surgical Inc. Corporate Office

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)208236, 237982
SPL set ID of the quoted label1408aabb-6982-48e5-ae9f-504ec43b0003
FDA labels (SPL)4
FDA applicationsNDA017697, NDA210850
Active ingredients (FDA)SINCALIDE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Kinevac, Bracco Diagnostics Inc., effective October 18, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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