Quick answers
- What is Barium sulfate used for?
- The FDA-approved label (E-Z-Paque, E-Z-EM Canada Inc, April 15, 2026) says: “E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Barium sulfate 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 Barium sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Barium sulfate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Barium sulfate?
- 2 companies list prescription products of Barium sulfate in the FDA NDC Directory, including E-Z-EM Canada Inc and E-Z-Em, Inc..
What Barium sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, duodenum and small bowel to visualize the gastrointestinal tract (GI) in adult and pediatric patients. …
— FDA label: E-Z-Paque, E-Z-EM Canada Inc, effective April 15, 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.
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 | Suspension · Powder, for suspension · Paste · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | E-Z-Paque, Readi-Cat 2, Varibar Nectar, Varibar Pudding, Entero Vu 24%, Readi-Cat 2 Berry Smoothie, Readi-Cat 2 Banana Smoothie, E-Z-Disk, Readi-Cat 2 Creamy Vanilla Smoothie, Varibar Thin Honey, Varibar Thin Liquid, Readi-Cat 2 Mochaccino Smoothie |
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.
- E-Z-EM Canada Inc15 products
- E-Z-Em, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208036 E-Z-CAT DRY, E-Z-HD, E-Z-PAQUE, VARIBAR THIN LIQUID | Bracco | January 11, 2016 | 4, latest April 30, 2019 2019: Efficacy · 2017: Efficacy · 2017: Labeling |
| NDA208143 ENTERO VU 24%, LIQUID E-Z-PAQUE, READI-CAT 2, READI-CAT 2 SMOOTHIE, TAGITOL V, VARIBAR HONEY | Bracco | January 15, 2016 | 8, latest March 10, 2022 2022: Manufacturing (CMC) · 2020: Efficacy · 2018: Efficacy |
| NDA208844 VARIBAR PUDDING | Bracco | October 14, 2016 | — |
| NDA219840 E-Z-DISK | Bracco | August 1, 2025 | — |
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.
-
April 13, 2022 · Class II · Terminated · D-1084-2022
cGMP deviations: Temperature abuse
E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01 — Mckesson Medical-Surgical Inc. Corporate Office
-
July 2, 2014 · Class III · Terminated · D-1536-2014
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01. — Bracco Diagnostic Inc
-
July 19, 2013 · Class III · Terminated · D-914-2013
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-54 — Bracco Diagnostics 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
| SPL set ID of the quoted label | 7225868a-4037-c96a-44e3-3326d36cbedc |
|---|---|
| FDA labels (SPL) | 12 |
| FDA applications | NDA208036, NDA208143, NDA208844, NDA219840 |
| Active ingredients (FDA) | BARIUM SULFATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — E-Z-Paque, E-Z-EM Canada Inc, effective April 15, 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 →