Most common reason: Wrong potency / content (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Irinotecan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Lack of Assurance of Sterility
Superpotent Drug: High out of specification assay value results for potency.
Superpotent Drug: High out of specification assay value results for potency.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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