CLASS I ONGOING Drug recall · Reported 19 Jun 2024 · FDA Enforcement Report
Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalled
Sagent Pharmaceuticals is recalling Docetaxel Injection, USP, 80 mg per (10 mg per mL), mL Multi-Dose Vial, distributed nationwide in the US. The recall was initiated on 28 May 2024 and the FDA has classified it as Class I.
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-0553-2024
- FDA event ID
- 94707
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Brand
- Docetaxel
- Manufacturer
- Sagent Pharmaceuticals
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 May 2024
- FDA classified
- 12 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 28 May 2024 | Recall initiated by company | |
| 12 Jun 2024 | Classified by FDA | +15 days |
| 19 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Product as listed by the FDA
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Where it was distributed
Nationwide within the USA.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Which lots are affected?
Lot #: F1040001, Exp. Date 12/31/2024
Where was it sold?
Nationwide within the USA.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 94707This product is part of a recall event; the main page for the event is Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
More recalls from Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per vial, For IV or IM Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Docetaxel recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Docetaxel injection concentrate, 20 mg/mL vial recalledDocetaxel | Sanofi-Aventis U.S | Potency & Assay | Nationwide |