FDA Drug recall D-0812-2016
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
- FDA Drug
- Class III
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class III recall of SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 by Jubilant Draximage, citing labeling: Label Error on Declared Strength.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0812-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-11 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Jubilant Draximage |
| Distribution | US |
Product
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Reason
Labeling: Label Error on Declared Strength
Identifiers
| ndc | 65174-461-05 |
|---|---|
| code_info | Lot Number 1670123; Exp 04/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0812-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.