Sanofi recalls Mozobil injection: Missing package insert risk
Sanofi recalls Mozobil (plerixafor) 24mg/1.2mL injections due to missing package inserts. This could affect patients using the medication for certain blood disorders.
Lower-risk recall
Labeling: Incorrect or Missing Package Insert
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What happened, in plain English
Sanofi is recalling Mozobil (plerixafor) injections because the package insert might be missing or incorrect. This could lead to patients not getting proper instructions for using the medication safely. Read more at govinfonow.com/recall/42462-sanofi-recalls-mozobil-injection-missing-package-insert-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42462-sanofi-recalls-mozobil-injection-missing-package-insert-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0704-2017
Cite this page
“Sanofi recalls Mozobil injection: Missing package insert risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42462-sanofi-recalls-mozobil-injection-missing-package-insert-risk. Based on FDA recall #D-0704-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0704-2017%22&limit=1).
Why it’s dangerous
The package insert contains important instructions for safe use. Without it, patients might not understand how to handle the medication properly, potentially leading to incorrect use.
Who’s affected
Patients prescribed Mozobil for certain blood disorders who have the specific injection product. Those using the medication without the correct package insert are at slightly higher risk.
How to tell if you have this one
Check for the product name 'Mozobil (plerixafor injection) 24mg/1.2m, 20mg/mL, single-use, prescription-only'. Look for NDC code 0024-5862-01 and lots 5RZ001C or 5RZ001D.
- Brand
Sanofi- Category
Drug
What to do — step by step
Check Package Insert
Ensure the package insert is present before using the injection.
How this recall unfolded
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.
Questions people ask
Is this product dangerous if the package insert is missing?
The recall is due to the risk of missing or incorrect package inserts, which could lead to improper use. However, the product itself is not dangerous if used correctly.
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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-0704-2017 (September 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0704-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.