Class II · Moderate risk
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Is Artesunate recalled?
Not under an active recall.
Artesunate was recalled 3 times in the past — all now closed. Most recent: Sep 27, 2021.
Most common reason: Cross-contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Artesunate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Artesunate recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Artesunate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Artesunate active pharmaceutical ingredient packaged in varying…
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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