Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cyclophosphamide for Injection Recalled by X-Gen Pharmaceuticals Inc. Due to Labeling: Incorrect or missing Package Insert: There is...
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 X-Gen Pharmaceuticals Inc. directly.
Affected Products
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Quantity: 1283 vials
Why Was This Recalled?
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About X-Gen Pharmaceuticals Inc.
X-Gen Pharmaceuticals Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report