Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Paclitaxel recalled?

Not under an active recall. Paclitaxel was recalled 7 times in the past — all now closed. Most recent: Jun 12, 2019.

Most common reason: Sterility / contamination (4 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Paclitaxel. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Paclitaxel recalls on record

none so far in 2026; 7 on record, newest first
Class II · Moderate risk

Paclitaxel Semi-Synthetic active pharmaceutical ingredient…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-829-2015
Class III · Low risk

Paclitaxel Injection

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Terminated Labeling / mix-up Fresenius Kabi USA, LLC NDC 63323-763-50 D-016-2014
Class II · Moderate risk

Paclitaxel Injection

The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

Terminated Particulate / foreign matter Hospira Inc. D-1682-2012
Class II · Moderate risk

Paclitaxel 6mg/Ml Injectable 500 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1591-2012