Sanofi-Aventis U.S. LLC recalls Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The
Sanofi recalls Clolar injection vials (20 mg/20 mL) because they lack the correct package insert for brand-name clofarabine. This affects authorized generic products.
Lower-risk recall
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Contact the company & request your remedy
What happened, in plain English
Sanofi is recalling Clolar injection vials that were packaged with the wrong package insert. This could lead to incorrect use if the patient doesn't have the proper instructions. Read more at govinfonow.com/recall/41137-sanofi-recalls-clolar-injection-vials-due-to-missing-package-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/41137-sanofi-recalls-clolar-injection-vials-due-to-missing-package-insert · Updated October 7, 2026 · FDA enforcement record: FDA #D-0056-2018
Cite this page
“Sanofi recalls Clolar injection vials due to missing package insert.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41137-sanofi-recalls-clolar-injection-vials-due-to-missing-package-insert. Based on FDA recall #D-0056-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0056-2018%22&limit=1).
Why it’s dangerous
The vials were packaged with the wrong package insert for the brand-name product Clolar. This means patients might not get the correct instructions for using the medication, which could lead to incorrect dosing.
Who’s affected
Patients prescribed Clolar injection by a doctor who received the generic vials from Teva Pharmachemle in Haarlem, Netherlands. Those using the vials without the correct package insert are at risk of incorrect dosing.
How to tell if you have this one
Check for vials labeled 'Clolar (clofarabine) injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only' made by Teva Pharmachemle in Haarlem, Netherlands. The vials were manufactured for Winthrop U.S. and have NDC 0955-1746-01.
- Brand
Sanofi- Category
Drug
What to do — step by step
Check Package Insert
Look for the correct package insert for Clolar injection in the vial's packaging. If missing, contact your doctor.
Questions people ask
Why is this product being recalled?
The vials were packaged with the incorrect package insert for the brand-name product Clolar, which could lead to incorrect dosing if the patient doesn't have the proper instructions.
How can I tell if I have the recalled product?
Check for vials labeled 'Clolar (clofarabine) injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only' made by Teva Pharmachemle in Haarlem, Netherlands with NDC 0955-1746-01.
What should I do if I have the recalled product?
Contact your doctor to check if you have the correct package insert. If missing, follow your doctor's instructions for next steps.
Contact Sanofi
We’ve drafted a message you can send Sanofi to request your refund or repair — edit it as you like.
Subject: Recall D-0056-2018 — Sanofi Sanofi Hello, I own a Sanofi that is covered by recall D-0056-2018 from Sanofi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0056-2018 (October 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0056-2018 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.