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Prescription medicine · generic available

Sucralfate

Brand names: Carafate

Drug class: Aluminum Complex

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
2Recalls (FDA reports)
42Companies
1981First FDA approval on file

Quick answers

What is Sucralfate used for?
The FDA-approved label (Carafate, Allergan, Inc., May 21, 2024) says: “INDI C A T I O N S A ND U S A G E CARAFATE ® (sucralfate) is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sucralfate have a boxed warning?
No. None of the 67 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Sucralfate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sucralfate been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started October 18, 2023 (Class I). A recall usually concerns specific lots, not every product.
Who makes Sucralfate?
42 companies list prescription products of Sucralfate in the FDA NDC Directory, including Bryant Ranch Prepack, Cardinal Health 107, LLC and Advanced Rx Pharmacy of Tennessee, LLC.

What Sucralfate is used for

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

INDI C A T I O N S A ND U S A G E CARAFATE ® (sucralfate) is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. …

— FDA label: Carafate, Allergan, Inc., effective May 21, 2024. Read the full label on DailyMed →

The FDA has 67 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 67 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Suspension
RouteOral
Prescription products70 in the FDA NDC Directory
Brand namesCarafate

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.

NADAC per unit for Sucralfate, by strength and form
Strength and formGeneric or brandPharmacies pay
sucralfate 1 g
tablet		 Generic $0.1694 per tablet
sucralfate 1 g
tablet		 Brand: Carafate $4.73 per tablet
sucralfate 1 g/10 mL
suspension		 Generic $0.1167–$0.1338 per mL
7 packages, lowest to highest

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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018333
CARAFATE		 AbbvieOctober 30, 1981 24, latest March 4, 2013
2013: Labeling · 2007: Labeling · 1995: Manufacturing (CMC)
NDA019183
CARAFATE		 AbbvieDecember 16, 1993 13, latest May 12, 2023
2023: Labeling · 2017: Labeling · 2016: Manufacturing (CMC)

Generic approvals (12)

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. October 18, 2023 · Class I · Terminated · D-0047-2024

    Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

    Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16 — VistaPharm LLC

  2. August 30, 2023 · Class II · Terminated · D-1149-2023

    Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

    Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16 — VistaPharm 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)208094, 208097, 313123, 314234
SPL set ID of the quoted labelc87c6b50-6977-4fa7-ae98-40c0753f7aee
FDA labels (SPL)67
FDA applicationsNDA018333, NDA019183, 12 ANDA
Active ingredients (FDA)SUCRALFATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Carafate, Allergan, Inc., effective May 21, 2024; 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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