Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Is Docetaxel recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Docetaxel (8 total). Check the affected lots below.
Most common reason: Packaging defect (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Docetaxel. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Docetaxel recalls on record
none so far in 2026; 8 on record, newest first
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
DOCETAXEL 60 MG / 250 ml D5W IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class II · Moderate risk
Docetaxel injection concentrate
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Class II · Moderate risk
Docetaxel Injection USP
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
Class II · Moderate risk
Docetaxel Anhydrous active pharmaceutical ingredient packaged in…
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.
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