Bracco E-Z-Paste Barium Sulfate Cream Recall: Failed Stability Test
Bracco Diagnostics recalls E-Z-Paste Barium Sulf: 454g tube with failed stability test for methylparaben. No remedy stated in official notice.
Recall notice
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Contact the company
What happened, in plain English
Bracco Diagnostics recalls a specific barium sulfate esophageal cream due to a stability test failure. This means the product may not be safe for use as intended. Read more at govinfonow.com/recall/40783-bracco-e-z-paste-barium-sulfate-cream-recall-failed-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/40783-bracco-e-z-paste-barium-sulfate-cream-recall-failed-stability · Updated October 7, 2026 · FDA enforcement record: FDA #D-0609-2018
Cite this page
“Bracco E-Z-Paste Barium Sulfate Cream Recall: Failed Stability Test.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40783-bracco-e-z-paste-barium-sulfate-cream-recall-failed-stability. Based on FDA recall #D-0609-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0609-2018%22&limit=1).
Why it’s dangerous
The product failed stability testing for methylparaben, a preservative. This could mean the cream may not be safe for use over time, though the exact risk isn't specified.
Who’s affected
People with prescriptions for this cream are affected. Those using it for esophageal imaging are at risk.
How to tell if you have this one
Check for the 454g tube labeled 'E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w)'. The product was manufactured by E-Z-EM Canada Inc. for Bracco Diagnostics Inc. in a specific lot number.
- Brand
Bracco Diagnostics- Category
Drug
What to do — step by step
Check Product Details
Look for the 454g tube with the product name and lot number 00538529.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Product was distributed throughout the United States, Hong Kong and New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0609-2018 (March 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0609-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.