CLASS II Drug recall · Reported 9 May 2018 · FDA Enforcement Report
Docetaxel injection concentrate, 20 mg/mL vial recalled
Sanofi-Aventis U.S is recalling Docetaxel injection concentrate, 20 mg/mL vial, distributed nationwide in the US. The recall was initiated on 27 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0804-2018
- FDA event ID
- 79964
- Recalling firm
- Sanofi-Aventis U.S, Bridgewater, NJ
- Brand
- Docetaxel
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Apr 2018 | Recall initiated by company | |
| 9 May 2018 | Published in enforcement report | +12 days |
| 14 May 2018 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
Where it was distributed
US nationwide
Questions about this recall
Why was it recalled?
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Which lots are affected?
Lot #: 7F307A, 7F307C, Exp 01/2019
Where was it sold?
US nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sanofi-Aventis U.S
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS II | Elitek (rasburicase) for injection, 7.5 mg vial recalledElitek | Sanofi-Aventis U.S | Potency & Assay | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Zantac 75 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Regular Strength Zantac 150 mg recalled by Sanofi-Aventis U.S | Sanofi-Aventis U.S | Nitrosamine Impurity | Nationwide |
Other Docetaxel recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Docetaxel 60 MG / D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Docetaxel Injection USP, 80 mg/, (20 mg/mL), One-Vial Formulation recalledDocetaxel | Dr. Reddy's Laboratories | Lead & Heavy Metals | Nationwide |