SODIUM IODIDE I 131 CAPSULE — Class III drug recall D-0812-2016
Terminated recall by Jubilant Draximage Inc, reported 2016-04-13, distributed nationwide. Labeling: Label Error on Declared Strength
| Recall number | D-0812-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Draximage Inc, Kirkland, N/A, Canada |
| Recall initiated | 2016-03-11 |
| Classified | 2016-04-06 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-08-07 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 65174-0461, 65174-0461-05 |
| Lot numbers | 04/16, 1670123 |
Product
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Reason for recall
Labeling: Label Error on Declared Strength
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-0812-2016. 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.