Paclitaxel recalls

The FDA has published 4 recalls involving Paclitaxel since 2012. The latest was reported on 21 Aug 2019. Most were for sterility. Infusion Options 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 recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Aug 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why paclitaxel is recalled

Companies

Infusion Options125%
Fresenius Kabi USA125%
Hospira125%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab125%

By year

2019125%
2013125%
2012250%

All paclitaxel recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Paclitaxel 258 MG / Ns Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY
4 Dec 2013Drug	CLASS III	Paclitaxel Injection, USP (semisynthetic) recalled by Fresenius Kabi USAPaclitaxel	Fresenius Kabi USA	Packaging Defects	Nationwide
26 Sep 2012Drug	CLASS II	Paclitaxel Injection, 6 mg/mL Single Dose Vial recalled by HospiraPaclitaxel	Hospira	Particulate Matter	Nationwide
22 Aug 2012Drug	CLASS II	Paclitaxel 6mg/ML Injectable (1 Product) recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Paclitaxel?

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.