Sanofi Elitek (rasburicase) injection recall: Failed stability testing
Sanofi recalls Elitek 7.5 mg injection vials due to stability issues detected in routine testing. This may affect patients with certain cancers. Contact Sanofi for details.
Lower-risk recall
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Contact the company
What happened, in plain English
Sanofi is recalling Elitek (rasburicase) injection vials that failed stability testing. This could mean the medication may not work properly for patients with cancer treatments. Patients should not use these vials without contacting their doctor. Read more at govinfonow.com/recall/36845-sanofi-elitek-rasburicase-injection-recall-failed-stability-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/36845-sanofi-elitek-rasburicase-injection-recall-failed-stability-testing · Updated October 5, 2026 · FDA enforcement record: FDA #D-1507-2020
Cite this page
“Sanofi Elitek (rasburicase) injection recall: Failed stability testing.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36845-sanofi-elitek-rasburicase-injection-recall-failed-stability-testing. Based on FDA recall #D-1507-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1507-2020%22&limit=1).
Why it’s dangerous
The medication failed stability testing, meaning enzyme activity levels were out of specification. This could lead to the injection not working as intended for cancer treatment. However, the recall does not indicate immediate harm to users.
Who’s affected
Patients prescribed Elitek for cancer treatment who have the specific vial described in the recall. Those with cancer receiving this medication are most at risk.
How to tell if you have this one
Check for Elitek 7.5 mg vials labeled with NDC 0024-5151-75, manufactured by Sanofi-Aventis U.S. LLC in Bridgewater, NJ, with lot number A9306 and expiration date 2/28/2022.
- Brand
Sanofi- Category
Drug
What to do — step by step
Check Medication Details
Verify the vial's NDC number, lot number, and expiration date to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1507-2020 (August 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1507-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.