E-Z-HD — Class III drug recall D-1536-2014
Terminated recall by Bracco Diagnostic Inc, reported 2014-08-20, distributed nationwide. Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testi
| Recall number | D-1536-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostic Inc, Monroe Township, NJ, United States |
| Recall initiated | 2014-07-02 |
| Classified | 2014-08-12 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 216,792 bottles |
| Reason classes | potency, specification failure |
| NDC | 32909-0764, 32909-0764-01 |
| Lot numbers | 05/15, 06/15, 64200, 64201, 64202, 64203, 64204, 64205, 64206, 64207, 64264, 64265, 64267, 64268, 64270, 64271 |
Product
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.
Reason for recall
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1536-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.