Docetaxel recalls

The FDA has published 7 recalls involving Docetaxel since 2018. The latest was reported on 19 Jun 2024. Most were for particulate matter. Sagent Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls7since 2018

Last 12 months0reported

Class I229% of total

Ongoing2latest 19 Jun 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 29%Class II 5 71%Class III 0 0%

Why docetaxel is recalled

Companies

By year

2024229%
2020114%
2019229%
2018229%

Ongoing docetaxel recalls

2 active

Reported	Class	Recall	Company	Reason	Where
19 Jun 2024Drug	CLASS I	Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel	Sagent Pharmaceuticals	Particulate Matter	Nationwide
19 Jun 2024Drug	CLASS I	Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel	Sagent Pharmaceuticals	Particulate Matter	Nationwide

All docetaxel recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
19 Jun 2024Drug	CLASS I	Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel	Sagent Pharmaceuticals	Particulate Matter	Nationwide
19 Jun 2024Drug	CLASS I	Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel	Sagent Pharmaceuticals	Particulate Matter	Nationwide
16 Dec 2020Drug	CLASS II	Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
21 Aug 2019Drug	CLASS II	Docetaxel 60 MG / D5w Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY
20 Mar 2019Drug	CLASS II	Docetaxel Injection USP, 80 mg/, (20 mg/mL), One-Vial Formulation recalledDocetaxel	Dr. Reddy's Laboratories	Lead & Heavy Metals	Nationwide
9 May 2018Drug	CLASS II	Docetaxel injection concentrate, 20 mg/mL vial recalledDocetaxel	Sanofi-Aventis U.S	Potency & Assay	Nationwide
17 Jan 2018Drug	CLASS II	Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation recalledDocetaxel	Dr. Reddy's Laboratories	Packaging Defects	Nationwide

Should you stop taking Docetaxel?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.