Jubilant Draximage Recalls Sodium Iodide I 131 Capsules Due to Labeling Error
Jubilant Draximage recalls Sodium Iodide I 131 capsules due to a labeling error regarding declared strength. Check lot numbers and expiration dates for affected units.
Recall notice
Labeling: Label Error on Declared Strength
Contact the company
What happened, in plain English
Jubilant Draximage Inc is recalling Sodium Iodide I 131 Capsule, USP Diagnostic Oral because the label declares an incorrect strength. This Class III recall involves 90 vials containing a total of 450 capsules distributed nationwide. The specific remedy for this recall has not been stated in the record. Read more at govinfonow.com/recall/43122-jubilant-draximage-recalls-sodium-iodide-i-131-capsules-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/43122-jubilant-draximage-recalls-sodium-iodide-i-131-capsules-due-to · Updated October 11, 2026 · FDA enforcement record: FDA #D-0812-2016
Cite this page
“Jubilant Draximage Recalls Sodium Iodide I 131 Capsules Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43122-jubilant-draximage-recalls-sodium-iodide-i-131-capsules-due-to. Based on FDA recall #D-0812-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0812-2016%22&limit=1).
Why it’s dangerous
The hazard is a labeling error where the declared strength on the package does not match the actual content. This discrepancy could lead to diagnostic inaccuracies or improper handling of the radioactive material, although the record does not specify any physical injury mechanism.
Who’s affected
Patients who have been prescribed or received Sodium Iodide I 131 Capsules from Jubilant Draximage Inc between March 2016 and April 2016. Individuals with vials matching the specific lot number and expiration date listed are at risk of receiving incorrect dosage information.
How to tell if you have this one
Look for Sodium Iodide I 131 Capsule, USP Diagnostic Oral manufactured by Jubilant Draximage Inc in Kirkland, QC, Canada. Affected items have NDC 65174-461-05, Lot Number 1670123, and an expiration date of 04/16.
- Brand
Jubilant Draximage- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Sodium Iodide I 131 Capsules match the NDC 65174-461-05, Lot Number 1670123, and Exp 04/16.
Contact Your Provider
Consult your healthcare provider or pharmacist regarding the labeling error and next steps for this specific lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0812-2016 (March 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0812-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.