CLASS III Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Sodium Iodide I, USP Diagnostic Oral recalled by Jubilant Draximage
Jubilant Draximage is recalling Sodium Iodide I, USP Diagnostic Oral, distributed nationwide in the US. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0812-2016
- FDA event ID
- 73586
- Recalling firm
- Jubilant Draximage, Kirkland, N/A
- Manufacturer
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Mar 2016
- FDA classified
- 6 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 11 Mar 2016 | Recall initiated by company | |
| 6 Apr 2016 | Classified by FDA | +26 days |
| 13 Apr 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength
Product as listed by the FDA
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Where it was distributed
Nationwide
Stores named: Costco
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength
Which lots are affected?
Lot Number 1670123; Exp 04/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Jubilant Draximage
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Draximage MAA (Kit for the preparation of Technnetium Tc recalledDraximage Maa | Jubilant Draximage | Sterility | Nationwide |
| Drug | CLASS II | Draximage Dtpa (Kit For The Preparation OF Technetium TC recalled | Jubilant Draximage | Potency & Assay | Nationwide |
Other Sodium Iodide I 131 recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Gelatin Capsule Pack for use recalled by RadnostixSodium Iodide I-131 | Radnostix | Packaging Defects | Nationwide |
| Drug | CLASS II | Sodium Iodide (I-131) Solution, Therapeutic Oral recalled by RadnostixSodium Iodide I-131 | Radnostix | Particulate Matter | Nationwide |