Sanofi recalls Docetaxel vials with over-concentrated drug
Sanofi recalls specific Docetaxel injection vials due to potential over-concentration. Patients should contact their doctor for guidance on safe handling.
Stop using this now
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Contact the company
What happened, in plain English
Sanofi is recalling certain Docetaxel injection vials that may have been over-concentrated. This could lead to serious health risks if used improperly. Patients should not use these vials and contact their doctor for alternatives. Read more at govinfonow.com/recall/40586-sanofi-recalls-docetaxel-vials-with-over-concentrated-drug.
Source Summary by GovInfoNow · govinfonow.com/recall/40586-sanofi-recalls-docetaxel-vials-with-over-concentrated-drug · Updated October 7, 2026 · FDA enforcement record: FDA #D-0804-2018
Cite this page
“Sanofi recalls Docetaxel vials with over-concentrated drug.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40586-sanofi-recalls-docetaxel-vials-with-over-concentrated-drug. Based on FDA recall #D-0804-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2018%22&limit=1).
Why it’s dangerous
Over-concentrated Docetaxel vials may cause severe reactions or harm when administered. The drug is highly potent and requires precise dilution for safe use.
Who’s affected
Patients prescribed Docetaxel injections who own the recalled vials. Those with specific lot numbers and expiration dates are most at risk.
How to tell if you have this one
Check for vials labeled 'Docetaxel injection concentrate, 20 mg/mL, 1 mL' with lot numbers 7F307A or 7F307C and expiration date 01/2019.
- Brand
Sanofi- Category
Drug
What to do — step by step
Stop using the vial
Discard the vial immediately if you have the recalled lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US 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 2.7 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- 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-0804-2018 (April 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0804-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.