Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Is Alteplase recalled?
Not under an active recall.
Alteplase was recalled 5 times in the past — all now closed. Most recent: May 20, 2024.
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 Alteplase. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Alteplase recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
cathflo activase
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Alteplase 1 mg/mL 1 mL in 10 mL syringe
Lack of sterility assurance.
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Alteplase
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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