Class II · Moderate risk
Cidofovir Injection 375mg/5mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Is Cidofovir recalled?
Not under an active recall.
Cidofovir was recalled 7 times in the past — all now closed. Most recent: Jan 2, 2019.
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cidofovir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cidofovir recalls on record
none so far in 2026; 7 on record, newest first
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Cidofovir injection 375 mg/mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class II · Moderate risk
Cidofovir Dihydrate 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.
Class II · Moderate risk
Cidofovir 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.
Class II · Moderate risk
Cidofovir Opthalmic Solution
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class I · High risk
Vistide (cidofovir)
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
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