Ganciclovir
Lack of sterility assurance
Most common reason: Sterility / contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ganciclovir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of sterility assurance
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Assurance of Sterility; container closure issues with the bulk batch.
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