Class II · Moderate risk
TRASTUZUMAB 427 MG / 250 ml NS IVPB
Lack of Assurance of Sterility
Is Trastuzumab recalled?
Not under an active recall.
Trastuzumab was recalled 3 times in the past — all now closed. Most recent: Jun 12, 2019.
Most common reason: Sterility / contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Trastuzumab. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Trastuzumab recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
ADO-TRASTUZUMAB 210 MG/250 ml NS
Lack of Assurance of Sterility
Class I · High risk
Trastuzumab Kit containing 1 vial Trastuzumab
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
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