Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irinotecan Hydrochloride Injection Recalled by Ingenus Pharmaceuticals Llc Due to Superpotent Drug: High out of specification assay value...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ingenus Pharmaceuticals Llc directly.
Affected Products
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Quantity: 14089 vials
Why Was This Recalled?
Superpotent Drug: High out of specification assay value results for potency.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ingenus Pharmaceuticals Llc
Ingenus Pharmaceuticals Llc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report